Medical Design & Outsourcing – JULY 2019

www.medicaldesignandoutsourcing.com JULY 2019

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8 MEDICAL DEVICE THE TOP 10 INDUSTRY SUPPLIER MEDICAL INNOVATIONS YOU DEVICE STATES NEED TO KNOW

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Here’s what it means for medical device industry suppliers

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THE U.S.-CHINA TRADE WAR:

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Medical Design & OUTSOURCING

medicaldesignandoutsourcing.com ∞ July 2019 ∞ Vol5 No4

E D I T O R I A L EDITORIAL Executive Editor Brad Perriello bperriello@wtwhmedia.com Editor Chris Newmarker cnewmarker@wtwhmedia.com @newmarker Associate Editor Danielle Kirsh dkirsh@wtwhmedia.com Senior Editor Nancy Crotti ncrotti@wtwhmedia.com Program Manager DeviceTalks Sarah Faulkner sfaulkner@wtwhmedia.com

VP Lifesciences Mary Ann Cooke mcooke@wtwhmedia.com 781.710.4659

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DESIGN & PRODUCTION SERVICES VP of Creative Services Mark Rook mrook@wtwhmedia.com @wtwh_graphics Art Director Matthew Claney mclaney@wtwhmedia.com @wtwh_designer Graphic Designer Allison Washko awashko@wtwhmedia.com @wtwh_allison Graphic Designer Mariel Evans mevans@wtwhmedia.com @wtwh_mariel

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HERE’S WHAT WE SEE

Welcome to the era of 'right-shoring'

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resident Donald Trump likes to brag about “literally hundreds of companies moving back” to the United States, and tariffs against a competitor such as China are a major part of the strategy.

At least with the medical device industry, though, the situation is more complicated.

The U.S.-China trade war is causing medical device industry executives to take a harder look at whether they should be manufacturing in the Asian giant — but they’re talking about shifting manufacturing to other low-labor-cost locations such as Malaysia, Thailand, Vietnam, Costa Rica or Mexico.

“They are looking at what I would call ‘rightshoring,’” Freudenberg Medical CEO Max Kley said of his company’s medtech customers.

That said, I’ve witnessed firsthand the vibrancy of the United State’s medical device manufacturing hubs in Minnesota, Massachusetts and California — three states alone where the industry provides more than 110,000 jobs. There are other smaller

The sector is thriving because when medtech reaches a level where there is little room for error, quality trumps labor costs. manufacturing centers in places such as Grand Rapids, Mich., and Warsaw, Ind. The manufacturing is advanced. The jobs require skills. The sector is thriving because when medtech reaches a level where there is little room for error, quality trumps labor costs.

If we truly want more manufacturing jobs in U.S., perhaps our government should find ways to better foster growth in medtech and other sectors that require advanced processes and skilled workers to make their products.

I encourage you to check out our cover feature, in which Kley and others provide a medical device industry supplier’s view of the U.S.-China trade war. Other highlights in this issue of Medical Design & Outsourcing include:

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• Medical device industry suppliers are increasingly coming up with their own answers to potential design and manufacturing challenges — enabling medtech innovation in the process. For example, Swedish company Trelleborg developed an advanced two-component injection technology to produce complex, high-precision parts for medical devices.

• California, Minnesota and Massachusetts dominate the U.S. medical device industry. But many other states also play a significant role in medtech. We looked up data including industry employment, venture capital investment, notable industry suppliers and more to compare the top medtech states in the country.

• The medical device industry and its suppliers are still dominated by men, especially when it comes to leadership positions. But there are a growing number of women executives making a difference in the medical device contract manufacturing space. We interviewed them to gain insights about how the industry could become more diverse. M

Chris Newmarker Editor Medical Design & Outsourcing cnewmarker@wtwhme di a .c o m

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CONTENTS

• • • • • THE CMOs ISSUE

medicaldesignandoutsourcing.com ∞ July 2019 ∞ Vol5 No4

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COLUMNS 6

HERE’S WHAT WE SEE

9

CONTRIBUTORS

12

AUTOMATION

16

COMPONENTS

ON THE COVER WHAT THE U.S.-CHINA TRADE WAR MEANS FOR MEDICAL DEVICE INDUSTRY SUPPLIERS

Welcome to the era of ‘right-shoring’

If the tariffs actually make a country great again, it might be Malaysia, Vietnam or Costa Rica, global medical device industry suppliers say.

How automation can boost medical device success UV light fights germs on mobile devices in healthcare

20 MANUFACTURING

Selecting the right contract manufacturer

24 MOLDING

Metal injection molding vs. machining: When MIM is best

28 PRODUCT LIABILITY

4 ways medical device manufacturers can reduce product liability risks

FEATURES

32 ROBOTICS

The robots are coming to medtech: Where’s the value?

36 SOFTWARE

How to avoid your medical device being hacked

52 8 MEDICAL DEVICE INDUSTRY SUPPLIER INNOVATIONS

YOU NEED TO KNOW

Medical device innovation doesn’t just come from startups or big corporate R&D departments. Contract manufacturers and suppliers are increasingly playing a role, too.

58 THE TOP 10 MEDICAL DEVICE STATES

38 TUBING TALKS

This swelling fluid helps boost medical tubing assembly

From industry employment to venture capital investment to notable industry suppliers, discover how the medical device industry’s top states compare.

68 3 WOMEN IN MANUFACTURING YOU SHOULD KNOW

42 VALIDATION

How to streamline sterile package validation

Here are insights from three women leaders making a difference in the medical device industry supplier space.

74 DEVICETALKS

Inside Insulet’s pivotal year with CEO Shacey Petrovic

78 PRODUCT WORLD

80 AD INDEX 8

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CONTRIBUTORS

BARRETT

BAUMGARTEN

PONTI

GOODMAN

RANDALL

HANNA

SANTORO

JEFF BARRETT is president & CEO of J-Pac Medical, a commercial packaging provider to medical device companies. He has more than 20 years of experience building high-growth medical device companies, including as CEO of GI Supply and Optim LLC and VP of operations at Haemonetics and Aspect Medical Systems (acquired by Covidien).

DON BAUMGARTEN is director of mechanical engineering for Product Creation Studio. He has participated in the design and manufacture of medical devices for startups to Fortune 500 companies, including Philips, Boston Scientific, GoPro, Pathway Technologies and Intellectual Ventures.

MICHAEL R. GOODMAN is a Greenberg Traurig attorney and registered patent agent advising clients in the medical device, pharmaceutical, biotechnology, consumer products, food and dietary supplement industries on FDA regulatory compliance and product liability.

CLAUDIO HANNA is a business development manager for Web Industries’ medical division. Hanna’s background includes more than 20 years in flexible goods, and in starting up manufacturing facilities and automation. Ponti has more than 15 years of experience with lateral flow devices.

MATT MOWRY is the product manager for Drylin for Igus North America.

PIGOTT

MOWRY

TENNISON

VAN NESS

JENNIFER PONTI is a business development manager for Web Industries’ medical division. Ponti has more than 15 years of experience with lateral flow devices.

WILL RANDALL is a manager with ZS in the medical products and services team, focusing exclusively on medtech clients. Will began his ZS career in the London office in 2009. He graduated with a First Class degree from Trinity College, Oxford University.

STEVE SANTORO is EVP of medical device contract manufacturer Micro, responsible for directing corporate technical and commercial teams.

He previously held high-level operations, sales, engineering and general management positions, and was recently appointed a charter board member of the School of Applied and Engineering Technology at the New Jersey Institute of Technology.

MERRITT TENNISON is a mechanical engineer for Product Creation Studio. He has developed products for Stanley Black & Decker, K2 Sports, Freefly Systems and Sandbol.

STEPHANIE VAN NESS is head of content development and senior marketing communications manager at Integrated Computer Solutions and Boston UX. She has written extensively about medical device development and cybersecurity.

GINGER HEYMAN PIGOTT is a shareholder and vicechair of Greenberg Traurig’s pharmaceutical, medical device and health care practice, handling highstakes products liability litigation with an emphasis on the defense of complex medical device and pharmaceutical products.

www.medicaldesign&outsourcing.com

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AUTOMATION

How automation can boost medical device success Automation doesn’t just deliver speed and cost savings. It provides many benefits with regard to manufacturing efficiency, quality, consistency and flexibility.

Automated manufacturing systems can typically scale to support major output increases without large additional expenses.

Image courtesy of Web Industries

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utomated medical device manufacturing is not all about reducing costs, though that certainly is a major long-term benefit. Other automation advantages are often overlooked and underestimated.

Claudio Hanna | Web Industries |

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Controlling consistency Automated medical device production reduces product variability and improves overall quality. The combination of cameras, sensors and computing technology on today’s automated machinery provides highly effective error detection and in many cases, automatic correction. For example, these systems can automatically detect if a device is out of tolerance while materials are moving inline at high speeds. By comparison, manual production requires a slow-down or stop so that samples can be evaluated by the human eye.

Ideally, an original equipment manufacturer (OEM) or developer should consider the role of automation very early in the device design process. It can be helpful to collaborate with a contract manufacturer that has automation expertise.

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By considering automation from a product’s inception, production partners can: • Ensure materials are available in formats suitable for high-volume, automated manufacturing processes.

• Identify how different automated production techniques can reduce product variability.

• Reduce cycle time required to transfer a manual or batch process to a fully automated process.

Increasing flexibility and responsiveness For some, automation may summon perceptions of being locked into rigid requirements, with little ability to change course if product parameters change.

However, the opposite is true. Welldesigned medical devices and automated production processes lend themselves to flexibility. For example, adjustments often can quickly be made to device dimensions and the position of product features.

Automation also gives medical device OEMs and developers the flexibility to easily scale up their production without adding costs. Whereas a manual batch

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AUTOMATION

Reduced scrap and improved product consistency are among advantages of automation in medical device manufacturing.

Image courtesy of Web Industries

production system might require significant labor and training investment to ramp up manufacturing, an automated system can typically scale to support major output increases without large additional expenses.

With automation, OEMs also reduce risks associated with dependence on laborintensive manufacturing. A case in point: By working with a highly automated U.S.based contract manufacturing organization (CMO), an OEM decreases the risk that its product supply might be interrupted by overseas labor issues or unexpected tariffs.

Reducing waste and improving productivity Automated systems can increase the yield from every production run, resulting in material savings. Consider these findings from a study by Kinematic Automation.

The study compared the production of 5 mm-wide medical test strips using two methods. The first method was manual.

Strips were cut from 333 30 cm cards. The second method was automated. Strips

were cut from a 100-meter material roll.

The scrap rate for the manual production method was 8.3%, whereas the scrap rate for the continuous reel-to-reel manufacturing method was less than 1%.

Investment payback Automation requires significant capital.

Often, a business will need to justify the investment by assessing it proportionally over the number of devices the automated equipment will produce. It is not profitable for companies to invest in underused equipment.

One benefit of partnering with a CMO is the opportunity to split the automation’s capacity and costs with other companies. Much like other shared services, this substantially cuts the costper-manufactured device. When manual labor is streamlined into high-precision machines, development and manufacturing teams can focus on improving efficiencies, expanding product lines and engaging in other profitable initiatives.

In conclusion, automation has myriad benefits beyond cost per device. In fact, it’s not about lower price; it’s about building better products. When device OEMs design with automation in mind and identify supply chain partners with automation expertise, they can improve consistency, reduce waste and respond more flexibly to market demand. M

A continuous reel-to-reel system like the one shown in this clean room environment offers cameras and sensors for automatic error detection.

Image courtesy of Web Industries

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COMPONENTS

How UV light fights germs on mobile devices in healthcare Ultraviolet rays quickly kill nearly 100% of bacteria found on mobile devices and could ease the spread of contamination in healthcare settings.

T Matt Mowry | Igus North America |

he increasing reliance on mobile devices to monitor patients, retrieve data and communicate among teams poses a serious contamination challenge in healthcare settings. Pathogens that build up on cell phones, tablets, personal computers and other technology equipment can spread quickly.

Studies have found that 94% of cell phones used by hospital staff bore contaminants, according to a 2017 report in Infection Control Today. The report also said that 89 medical workplace employees were aware their mobile devices could be a source of contamination, yet only 13 disinfected their phones regularly.

The CleanSlate UV Sanitizer disinfects cell phones, laptops and other mobile devices in 20 seconds, according to CleanSlate UV. Image courtesy of CleanSlate UV

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A new device may offer a swift and safe solution. The CleanSlate UV Sanitizer uses ultraviolet light to eradicate 99.9998% of methicillin-resistant Staphylococcus aureus (MRSA) in 20 seconds, according to manufacturer CleanSlate UV. UV light acts as a cleaning agent The CleanSlate sanitizer uses shortwavelength ultraviolet light (UV-C), which destroys nucleic acids and breaks apart germ DNA, preventing pathogens from functioning or reproducing. UV light won’t harm touchscreens, cameras or IR sensors, and is optimal for hard, nonporous surfaces. Unlike chemical wipes, UV-C light does not dry out or degrade materials, according to CleanSlate UV. The user deposits the mobile device into the machine, closes the lid and waits 20 seconds for the device to be cleaned. Once completed, the lid opens automatically and the mobile device can be removed. The device can sanitize multiple items at once, and includes RFIDenabled tracking and compliance auditing.

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COMPONENTS

Medical Device Manufacturing From Concept To Market We are vertically integrated to provide you with all the services and capabilities essential for complete medical device contract manufacturing.

• Clean Room Assembly • Custom Tubing Solutions • MIM (Metal Injection Molding) • Precision Machining • Insert/Injection Molding • Precision Metal Stamping

A key component One of the device’s critical components is a sliding chamber made of Drylin W parts manufactured by motion-plastics company Igus (Cologne, Germany). The sliding chamber is the open front end of the product, into which the user deposits the mobile devices. Once the lid is closed, the sliding chamber transports the device into the UV chamber.

The Igus Drylin W guides are highly flexible and designed to slide rather than roll. By contrast, rolling mechanisms use moving parts, which may decrease a product’s reliability and generate more noise. Igus’s sliding mechanism eliminates those issues and the number of parts required is reduced significantly, lowering costs.

“Since the UV light is dangerous to human skin and eye, we had to design a moving chamber that transports the device into the UV chamber when the sanitization was initiated by the user,’’ explained Kevin Wright, Canadian sales manager for Igus, which has North American operations in Providence, R.I. “It was important to have a bearing system that was extremely quiet, especially in the evening shifts where any noise from the devices can be disturbing to the patients and staff.”

Drylin W guides are typically used in agricultural machinery, vehicle construction, packaging, furniture and robotics. Their resistance to dirt and dust contributes to the CleanSlate UV device’s reliability, according to the company.

The CleanSlate UV Sanitizer includes Drylin W linear guides from Igus, which are resistant to dirt and dust due to dry operation.

Image courtesy of CleanSlate UV

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“Reliability was utmost, as any downtime due to CleanSlate device breakdown would result in the ineffective sanitization of mobile devices using chemical wipes, which could damage or degrade the electronic devices used in hospitals,’’ said Manju Anand, chief technology officer for CleanSlate UV. International acceptance More than 40 hospital systems, biotech companies and food processors in the United States, Canada, Australia and Hong Kong are using CleanSlate UV Sanitizers, according to the company.

Montfort Hospital in Ottawa recently installed one near its coffee shop and another in a patient care unit.

“UV light is being incorporated in different types of technologies for the purpose of disinfection,’’ said Josée Shymanski, manager of infection control at Montfort Hospital. “Using UV light to target mobile device disinfection filled a need that existed

and which will continue to exist as we move more and more toward electronic technologies in health care.”

Many patients, staff and visitors clean their cell phones and other mobile devices using the new technology in a main hospital lobby or while waiting to order coffee, according to Heather Candon, manager of infection prevention and control at Mackenzie Health, another hospital system in Ontario. “This is a good habit to practice all year-round, but even more so during flu seasons,” Candon said. M

Reliability was utmost, as any downtime due to CleanSlate device breakdown would result in the ineffective sanitization of mobile devices using chemical wipes, which could damage or degrade the electronic devices used in hospitals.

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MANUFACTURING & MACHINING

How to select the right contract manufacturer Understanding the technical capabilities and business priorities of contract manufacturers is essential to selecting the best manufacturing partner.

Here are five key areas to focus on when choosing a medical device manufacturer.

P

M e r r i t t Te n n i s o n | Product Creation Studio |

erhaps you’ve heard horror stories about the difficulties of working with a contract manufacturer — cost overruns, quality issues and schedule delays. Even one of these issues can disrupt a medical device product launch and hurt your business.

Carefully selecting a contract manufacturer (CM) can help you avoid those problems. The right CM can provide guidance to optimize your product design for manufacturing and assembly and keep your project on track.

Here are key strategies to ensure you select the right contract manufacturer for long-term success.

Identify your needs Before starting your search, identify the manufacturing capabilities needed

Don Baumgarten | Product Creation Studio | 20

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for your product. Understanding your business needs and priorities will help you evaluate your options and decide which CM is best suited for you. For example, you may need to choose between a CM that offers the best pricing but cannot meet a critical schedule date, and another CM that can meet your schedule, but at a higher price.

What are your product’s defining characteristics?

CMs typically specialize in manufacturing certain product types and develop the requisite manufacturing technologies, supplier networks, and quality systems. Identify CMs that specialize in your product type so you can be confident they can manufacture your product.

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MANUFACTURING & MACHINING

What annual production volumes are you forecasting?

The answer will help a CM determine three critical things — how quickly they would need to scale production, where they would manufacture your product, and how well the volumes align with their operations. CMs generally optimize their manufacturing facilities, resources and supply chain network for specific annual production volumes. You’ll need estimates for short-term and long-term production quantities to determine if the CM’s operations are a good fit for your product.

What are your special needs?

Do you need initial production units quickly? Is minimizing the cost of goods critical to your business model? Does your product require highly specialized manufacturing and quality control processes? Even the best CMs have their limitations. Identifying the unique demands of your product and business will help you communicate clearly with prospective CMs.

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Don’t delay the search Start your CM search as soon as a preliminary engineering design is complete. This will allow CM candidates to understand your specific manufacturing needs and give you an opportunity to incorporate their ideas as you optimize your design for manufacture and assembly.

Have your top three to five candidates sign non-disclosure agreements so you can discuss project and product information in detail. Having an on-site visit — at either party’s place of business — is crucial for both parties to get to know each other, ask questions, and get an idea of what the working relationship would look like moving forward.

If unique manufacturing processes or testing capabilities are integral to the product, it may make sense to visit the CM. Otherwise, simply having the right stakeholders in the same room can serve as a platform for answering questions, discussing product requirements and establishing next steps. Depending on how

What are your product's defining characteristics?

What annual production volumes are you forecasting?

What are your special needs?

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Celebrating the

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complete your product engineering design is, it can also be a good opportunity to review the technical design in detail.

Be transparent Honesty about your cost targets, critical project milestones and CM selection criteria will help the CM understand your priorities so they can express concerns about meeting your objectives. Also, explain the types of expertise you need, such as the CM’s supply chain network or design optimization experience. This will help identify the CMs that can best support your team.

Consider all costs Choosing the CM with the lowest manufacturing cost won’t necessarily save you money. Quotes will often include the term “FOB,” which stands for “free on board,” followed by the name of the shipper’s (CM) port. This means once the products are loaded onto a shipping vessel, the buyer is responsible for paying all transportation, duties and insurance costs involved in moving product from the buyer’s port to distribution. Include these costs when preparing quotes.

Find the perfect match As you’re evaluating potential CMs for your product, know that the CMs are assessing how well your manufacturing needs fit their business model. In other words, you can’t select a CM as your manufacturing partner unless the CM selects you as a customer. From the CM perspective, you’re an attractive customer if your product type aligns with their supply chain network and manufacturing expertise and your production volumes meet their targets.

Provide the top CM candidates with a request for proposal that contains the information they need to provide a quotation for goods and services. CM quotations should include itemized part and assembly costs, tooling costs, and identification of specialized manufacturing or process development costs.

With several quotes in hand and the insights gained during your search, you can confidently select the best contract manufacturing partner for your product and business needs. M

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MOLDING

Metal injection molding vs. machining: When MIM is best Metal injection molding (MIM) works well for highvolume production of small, complex medical device parts of consistent quality.

Steve Santoro | Micro |

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Medical Design & Outsourcing

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D

emand for small, lightweight, high-strength, complexly shaped components is growing across industries today, from automotive, consumer electronics, aerospace and defense to orthodontics and medical devices.

Traditional machining and injection molding each has its pros and cons in producing components for medical devices, especially where parts may be smaller and require more maneuverability. Metal injection molding (MIM) is a hybrid technology that integrates the shaping capability of plastic injection molding and the materials flexibility of conventional powder metallurgy. Material selection, part size, volume and tolerance are all instrumental factors in the decisionmaking process.

7 • 2019

Materials MIM is a process like plastic injection molding but with metal feedstock. Powdered metal feedstock is processed at high temperature and pressure to effectively and efficiently produce small, precision, high-performing parts in large quantities. This proven technology yields high-quality mechanical properties and excellent strength, ductility and magnetic response. It’s ideal for creating components with more sophisticated shapes and small, highly precise parts with unique geometries for surgical instruments, artificial joints and pacemakers.

Process overview When using injection molding, it’s important to remember not all feedstocks and processes are equivalent. For optimal

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THE ORIGINAL MEDICAL PUSH-PULL CONNECTOR

MOLDING

mechanical properties, high density and small dimensional variation, it’s critical to obtain consistent shrinkage and diffusion of organic binders and surfactants from the metal matrix. Poor diffusion increases the voids in the metal matrix by trapping gas; the lower density will dramatically reduce the strength of the part.

Due to the flexibility of MIM technology, it’s possible to customize material compositions according to the specific attributes required by customers.

Some of the compositions are stainless steels, low alloy steels, carbon steels, Nialloys, tool steels and tungsten alloys.

Part size MIM is preferred for mass manufacturing of small, intricate geometric components of a variety of materials, as it can achieve 95% to 98% of its theoretical density at a much lower cost than comparable machined components.

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Volume MIM is well-suited to automation in producing large quantities with consistent quality. Machining typically requires longer cycle times and is thus better suited for lower production volumes requiring complex shapes with tighter tolerances.

Finishing operations with MIM are quite minimal by comparison so long as the application has less critical tolerances. Although there’s an initial capital investment in creating the MIM mold, this cost can quickly be recovered when amortized over high-volume runs.

larger the propagation of error. One other phenomenon that affects expected outcomes is non-isotropic. There will be more shrinkage in the vertical direction because of gravity. The least shrinkage will occur in the longest lengthwise direction due to drag forces between the workpiece and the furnace furniture.

MIM is ideal for producing intricately shaped parts for complex components as well as parts that require assembly. The same is true for highproduction of small precision parts with complicated design geometry.

The process lends itself to automation in which high volumes and consistent quality are required. MIM technology is also the best viable process for producing miniature parts economically.

Companies that specialize in MIM technology and machining should work alongside engineers to address development early on. Engineers with expertise in both processes can suggest design modifications and provide input to get the best performance out of a product no matter what technique is ultimately used. While you can certainly switch operations midstream, factoring in design considerations upfront can save time and costs. M

Tolerance Expected tolerances range from +/- 2% to less than 0.4%, depending on feature size. The larger the feature, the larger the tolerance due to the propagation of error in shrinkage. Shrinkage generally ranges from 15% to 18% during sintering.

Therefore, the larger the feature, the 26

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Medical Design & Outsourcing

7 • 2019

Typical MIM parts used in disposable surgical instruments and assembled in a clean room.

Image courtesy of Micro

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PRODUCT LIABILITY

4 ways medical device manufacturers can reduce product liability risks Product liability can be company-ending for a medtech company.

Here are four key considerations to mitigate the risk.

M

Ginger Pigott | G r e e n b e r g Tr a u r i g |

edical device manufacturers have many goals, but central is the ability to improve or extend life, to add value to or improve medical treatment and/or be a benefit to patients.

In our world of litigation and exposure to potential company-ending liability, it is not only good intentions or successful execution of concept that win the day in court. To survive, to innovate and keep valuable products on the market includes understanding and utilizing the protections afforded by the regulatory framework and case law interpreting how prescription medical devices are to be treated in tort litigation.

While there are many ways to help mitigate or reduce risk, here are four keys to keep in mind: Key No. 1: The regulatory pathway to market has an impact on tort claims.

Pathway to market decisions often involve a calculus of time versus cost and availability

of options. However, classification of the device and approval versus clearance can make a big difference in how manufacturers are treated if or when they face lawsuits.

Class III devices on the market after successfully navigating the rigorous Premarket Approval (“PMA”) process have the most robust defenses to traditional tort claims — like negligence, strict liability and routine breach of warranty allegations. This is because by virtue of the approval the FDA imposes device-specific “additional requirements” that if followed preempt traditional product liability claims. And, while plaintiff’s attorneys continue to explore ways to circumvent the dispositive impact of preemption, it is strong leverage to early disposition of legal cases to have PMA. Class II devices are generally “cleared” by a Premarket Notification (“510(k) clearance”) pathway. (Most Class I devices are exempt from 510(k) clearance, although there are certain registrations and other requirements for this class of devices under

Michael Goodman | G r e e n b e r g Tr a u r i g |

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PRODUCT LIABILITY

FDA regulations.) Devices cleared under a 510(k) use a “substantial equivalence” test comparing to a predicate device to get to market. Since the test does not involve more arduous clinical trial and other requirements of an approval, it is not considered a reflection of the necessary FDA device-specific special controls.

Because they are cleared without device-specific special controls, preemption does not typically apply, and litigation almost always involves great expense and very often the exclusion of some key FDA involvement evidence. But this may be changing.

Recently, the FDA issued a draft guidance expanding the abbreviated 510(k)-clearance pathway. This pathway may tip the scales in favor of preemption for Class II devices. It encourages nonclinical and clinical performance evaluations — as established by the FDA — that provide reasonable assurances of the safety and effectiveness of the particular device as compared to its

predicate. These special controls may provide you with access to a preemption defense. Some cost up front may help with legal defense down the road.

Key No. 2: Consider your promotional and warranty language.

Regardless of its regulatory status, what you say about your device will be part of the landscape lawyers consider when evaluating an alleged claim of failure to warn, misrepresentation, breach of express warranty and other claims that rely on what was said or not said.

Here are two examples for consideration: First, express warranties for Class III devices should be precisely tailored to the PMA application. General breach of express warranty claims against a Class III device generally fail for preemption.

Making an additional warranty, however, may be stepping away from the protective cloak of preemption. The takeaway here is not to remove express warranties — Class III devices certainly benefit from assuring

their devices — but instead ensure that the warranties are strictly tailored to precisely what the FDA reviewed and approved or be willing to abide by these separate promises.

Second, be careful of what your website or other materials say about the characteristics of the device. Not all states will protect you from a claim that such statements are in fact “warranty” language notwithstanding the statements are outside of the express warranty that accompanied your product. Sticking with the words approved or reviewed by FDA can help legal defenses down the road.

Key No. 3: The duty to warn runs typically to the treating physician — the learned intermediary — so keep it that way.

If you design, manufacture and/or distribute prescription medical devices, you need to direct warnings, instructions and precautions to the physician. The physician bears the responsibility to obtain informed consent, including conveying appropriate warnings. You

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BIOCOMPATIBLE LED Curable Adhesive are not required to warn patients, and are generally sheltered from “failure-to-warn the patient” claims.

While you may still get a “failure-to-warn” claim about the adequacy of labeling for the physician, those claims are often weak, particularly if you have both clear warnings and physicians who know their business.

But without being careful, direct-to-consumer and online labeling may dilute or even waive a “learned intermediary” defense by touting a medical device’s efficacy without sufficiently warning of the contraindications. However, you can mitigate this risk by including in such communications the verbiage approved

by FDA (if you have PMA) or submitted with your 510(k)clearance submission. As a rule of thumb, if you are already selling a device, your advertisements or consumer facing communications should be limited to the (1) device name, (2) FDA-approved or cleared use, and (3) most significant risks of your device.

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If you design, manufacture and/or distribute prescription medical devices, you need to direct warnings, instructions and precautions to the physician.

Key No. 4: Sales teams need to stay ‘on label’ and ‘on message.’

The ways sales employees can impact litigation for your products is significant enough that it deserves a series of articles. For now, we remind you that what your teams are saying and doing in the field is key and what you do about training and discipline for such activities (including compliance with your protocols) is often important since plaintiffs’ attorneys, facing preemption and other legal defenses to traditional claims, will look to activities of your field personnel to see if anything there might provide a hook to keep a claim in court.

One example for consideration: Off-label use promotions that are truthful descriptions of scientific information have First Amendment protections from FDA enforcement.

Regardless, the exposure to legal claims by promoting off-label uses is typically far greater than any gain. Courts are extremely favorable to patients’ product liability claims who can tie off-label promotion to both its off-label use and to injury. It is important to avoid using social media or websites to promote devices for off-label uses. This includes prohibiting employees from “liking” patients’ positive posts describing an off-label use. Requests for off-label information from physicians should be directed to medical affairs where a uniform and considered response can be provided.

There are a lot of ways you can set your company and products up to help mitigate and reduce potential product liability exposure. Thinking about this early and in conjunction with other decisions is a valuable exercise. M 7 • 2019

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ROBOTICS

The robots are coming to medtech: Where's the value?

As each medtech manufacturer gears up to bring robots to surgery, theyâ&#x20AC;&#x2122;ll need to create an outcomes-oriented value story to compete.

Medtronic in December 2018 closed on its $1.7 billion purchase of Mazor Robotics and its robotassisted surgery platform for the spine, launching its Mazor X Stealth platform in the U.S. a month later.

Image courtesy of Medtronic

Will Randall | ZS |

T

he biggest medtech headlines so far in 2019 tell a consistent story: The robots are coming.

From Medtronicâ&#x20AC;&#x2122;s $1.6 billion acquisition of Mazor in late December to Johnson & Johnson dropping $3.4 billion on Auris Health in the first quarter, many major players are making significant investments in robotics.

The robot-assisted surgery market is estimated to reach $5.6 billion by 2025, according to Grand View Research. The market is poised for explosive growth, and for good reason: Robotic innovations are dramatically reshaping the practice of surgery, with the potential to be leveraged from diagnosis to incision.

Robotics in medtech: Evolution or revolution?

The growth in robotics could start to fill operating theaters with ever more highly

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7 â&#x20AC;˘ 2019

specialized capital equipment. With onethird of U.S. hospitals already running at least one robot, will the gap continue to widen between hospitals that specialize in robotic procedures and institutions without any robotics capabilities? Or in an alternative future scenario, might the early adopters of robotics be unable to stay at the forefront of procedure innovation simply because of a lack of space in their facilities for more robots? For manufacturers lining up to commercialize their technologies, these scenarios mean that they must choose whether to focus on a small set of robotics-oriented specialists or try to maximize the breadth of penetration of the technologies via a land-grab strategy. First movers certainly could gain an advantage if they embed their technologies before their peers in either scenario.

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ROBOTICS

as the major players rush to develop and commercialize their technologies.

Although the power and potential of these technologies is transformational, robotics offerings are also helping some companies reap short-term rewards and stay relevant at the operating table. Stryker reported that its Mako knee replacement surgery robot drove significant share gains for its devices in 2018. The Kalamazoo, Mich.â&#x20AC;&#x201C;based orthopedic device giant has reported more than 76,900 knee and hip replacement procedures performed in 2018 and double-digit growth in installations expected in 2019.

As a closed system, the robot installation drives market share from competitors toward Stryker implants. It will be interesting to see how Zimmer Biomet leverages its Rosa knee surgery robot to regain that lost market share, or whether it pursues a different strategy on launch this year. If we see a strategy of placing a Rosa robot into a Mako

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account to regain share equilibrium, it will suggest that there is limited differentiation between the robots beyond being a short-term tool to drive device sales. On the other hand, if we see that Mako robots have closed the door to competitors, it will be much more of an uphill battle to regain market share.

Next-generation value proposition As more players enter the robotics space, successful differentiation and sustained growth will not come from the features and benefits of a given robot alone. The full shift toward robotics will become imperative if health providers can realize benefits including reduced hours in operating rooms, lower readmission rates, better recovery times and less postsurgery trauma.

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â&#x20AC;˘ Aligning robotics offerings to missioncritical customer needs: Robot-assisted techniques are driving improved outcomes for complex procedures. Realworld evidence shows a 50% reduction in surgical blood loss and a 70% reduction in length of stay through robotic-assisted techniques, which means that robots could be mission-critical for hospitals that are still conducting less efficient traditional surgical procedures and getting poorer outcomes.

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As the buzz around robotics continues to build, we could see a robotic arms race as the major players rush to develop and commercialize their technologies.

• Supporting outcomes expectations with measurable data: The outcomes that surgical robots promise must be measurable.

How and why is robotically assisted surgery better than open surgeries? At what rate are the surgical complications decreasing? For example, data shows that Medtronic’s Mazor Core System leads to reductions in the rate of surgical complications and revision surgeries compared to traditional minimally invasive spine surgery. We expect manufacturers to leverage such data generated by existing robot users to reinforce the value of robotics and demonstrate impact to other prospective customers.

• Ensuring that outcomes are achievable: Training is essential to deliver the outcomes that are promised by robotics, but with hospitals spending thousands of dollars to train each physician to use a robot, this could be a potential barrier. If manufacturers help customers seamlessly implement robotics technologies, their customers will see a quicker return on their investments. We will likely see many companies providing high levels of support to new users, with representatives present every time surgeons use robots, but this support should be strategically deployed to ensure rep presence is creating value for the end users and institutional outcomes.

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• Translating better outcomes to higher financial impact: Robotics investments are significant, so the costs need to be clearly justified. For instance, Stryker emphasizes that its Mako system reduces 66% of the readmission costs. By quantifying the economic benefit of their robots, manufacturers can help potential buyers swallow the $1-million-plus price tags. For those who cannot, alternative payment options such as rentals and leases will be more common.

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As each manufacturer gears up for its own “year of the robot,” it’s time for them to put these foundational principles in place to shape an outcomes-oriented value story to capitalize on the market opportunities ahead. M www.medicaldesignandoutsourcing.com

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Medical Design & Outsourcing 35

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SOFTWARE

How to avoid having your medical device hacked Leaving a medical device vulnerable to hacking is just too risky. Medtech manufacturers can take several steps to lessen the likelihood of such attacks.

F

rom pacemakers to light scopes to infusion pumps, today’s connected medical devices not only appeal to clinical users but cybercriminals as well. The potential for security breaches should alarm device manufacturers and users, as breaches can put patients’ lives, customers’ sensitive data and companies’ financial futures at risk. Meticulous, security-conscious development can be the antidote to cyberhacking.

S t e p h a n i e Va n N e s s | Integrated Computer Solutions |

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A growing menace Thanks to the rise of the Internet of Things (IoT) and the push for greater connectivity, more devices — and more-sensitive devices — are susceptible to malicious hackers. In the U.S. there are 10 to 15 connected devices per hospital bed, many

7 • 2019

of which are vulnerable to cyberattack, according to a report by Alpine Security.

Medtronic made news in March 2019 when it disclosed a security flaw in some of its implantable defibrillators that allow for remote monitoring. This disclosure was made after the Dept. of Homeland Security flagged a critical cybersecurity weakness in one of the company’s cardiac devices, rating the weakness 9.3 on a 10-point vulnerability scale. The flaw, present in the device’s Conexus wireless communication protocol, could allow unauthorized access and changes to the settings of the device and at-home monitors.

In 2017, the FDA recalled 465,000 radio-controlled implantable cardiac pacemakers made by St. Jude Medical.

The reason: too much potential for cybercriminals to hack the devices. For instance, hackers could run down the batteries or alter the patient’s heartbeat, both worst-case scenarios that could result in the death of the patient. Affected patients did not have to have the devices removed. Instead, Abbott, which owns St. Jude, issued a firmware update in 2018, incorporating more stringent security.

Certainly, networked devices allow physicians and other professional caregivers access to expansive data, which can lead to better patient outcomes. In fact, Medtronic suggested the remote monitoring feature of its flagged defibrillators delivers substantial-enough benefits to outweigh the potential security risks. Still, it’s clear that stringent security measures are necessary when developing and using connected medical devices, especially given the number of device makers looking to leverage these devices’ capabilities.

www.medicaldesignandoutsourcing.com

Image courtesy of Adobe Stock

7/23/19 3:37 PM

Critical steps for building connected devices • Build security into IoT applications and devices during the design phase.

• Prevent unauthorized users from gaining access.

• Limit data collection to information required for the device to operate as intended; only keep data for the shortest amount of time necessary.

• Design products to ship with unique credentials, or require users to set new credentials the first time they use the device.

• Monitor the health of devices and provide patches as soon as vulnerabilities are identified Last year, the U.S. Dept. of Health & Human Services recommended that device makers and the FDA conduct presubmission meetings to better address questions regarding networked-device cybersecurity. The FDA asked manufacturers to provide the information below in their submissions: • Hazard analysis listing the cybersecurity risks considered and the cybersecurity controls incorporated into the device.

• Traceability matrix linking the actual cybersecurity controls to the risks that were considered.

• Manufacturer’s plans for validating and updating device software.

• Description of controls in the software supply chain.

For healthcare organizations, designing security measures in their systems from the outset should be fundamental, as is addressing security at the network and application levels.

On the network level, that may involve guarding against an imposter device sending incorrect information that could corrupt application data. Regarding the application layer, which includes web, mobile or cloud-based applications connected with the device, security must be addressed during both design and development phases, as well as during testing. Penetration testing of embedded and connected devices can help confirm they’re secure.

For devices users, whether that’s the nurse or physician in a clinical setting or a patient or non-professional caregiver in a home setting, the key is to remain vigilant by addressing basics like changing default passwords when setting up a device. According to IBM, most consumers don’t change factory settings, yet many IoT devices are shipped with default usernames and passwords that can be found with a simple Google search.

Shared responsibility It’s impossible to build a 100% secure device — hackers are simply too skilled and too motivated, and increasingly sophisticated technologies are continuously emerging — but the consequences of a malicious medical device hack can be devastating. All stakeholders, including device manufacturers, healthcare organizations, care providers and patients, must be responsible for cybersecurity. Cybersecurity experts and the FDA should also do their part to ensure that using these devices does not pose an unacceptable level of security risk. M 7 • 2019

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A Pressing Need, A Unique Event The combination of innovative research, powerful, lowcost enabling technology, and the support of business, government and academic leaders, would seem to bode well for the commercial prospects of healthcare robotics.

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TUBING TALKS

This swelling fluid helps boost medical tubing assembly MicroCare Medical has earned success selling its Swellex silicone swelling fluid to companies assembling medical tubing. Here’s how it works.

Chris Newmarker | Editor |

David Ferguson | MicroCare |

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icroCare Medical (New Britain, Conn.) over the past decade has found that its Swellex silicone swelling fluid is a popular product for medical tubing manufacturers.

“That’s because the swelling fluid helps workers reduce the amount of force needed to insert a tube onto a barb or other type of connector,” David A. Ferguson, senior market and technical manager at MicroCare, told Medical Design & Outsourcing.

Whether the manufacturing involves assembling IV tubes and bags, drainage catheters, dialysis machine tubing or a host of other products with tubing, companies are avoiding having to throw out tubing because of stress cracks, according to Ferguson. Swellex is also helping employees avoid carpal tunnel, wrist problems and other workplace-related injuries.

“Since you don’t want to introduce heat, glue or anything else that can affect the integrity of the tubing or has to be qualified with the FDA, tubing is typically assembled by hand. Swellex helps make

7 • 2019

it easier,” said Ferguson, who spoke with MDO during MD&M West early this year.

A worker can soak a dozen tubes in Swellex for 10 to 15 minutes – until the inner diameters of the tubes soften and swell enough that they can be easily attached, Ferguson said. The tubes then contract to their original shape, size and strength, forming a tight, leak-proof grip as the Swellex quickly evaporates.

The process produces no residue affecting the qualification of the manufacturing process under FDA guidelines, according to Ferguson.

LEFT: Swellex temporarily softens and swells the inner diameter of a silicone rubber tube so that it can be easily attached to a barb or other connecter, as David Ferguson from MicroCare Medical demonstrated at MD&M West in February.

RIGHT: A worker can soak a tube in Swellex for 10 to 15 minutes – until the inner diameter of the tube softens and swells enough that it can be easily attached.

Images by editor Chris Newmarker

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TUBING TALKS

Since you don't want to introduce heat, glue or anything else that can affect the integrity of the tubing or has to be qualified with the FDA, tubing is typically assembled by hand.

Because the swelling fluid’s active ingredient is a methyl siloxane — a member of the silicone family — it doesn’t affect the integrity of the tubing, he said.

The Swellex swelling capabilities are similar to those of hexane, but there is less weight gain due to swelling absorption, which enables the polysilicone tubing to return to its original state faster, according to MicroCare. The company also touts Swellex as VOC exempt, making an excellent replacement for hexane or tolulene.

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Much of the use for Swellex involves tubing made of silicone rubber, a go-to material for medical tubing. The swelling fluid, however, is compatible with other tubing materials, including polyethylene and polyimide, but prior in-use testing is important, Ferguson said. MicroCare also has a second swelling agent called Swellex P, a proprietary formulation that works on polyurethanes.

Ferguson acknowledged that there are a few challenges manufacturers should address before using Swellex: • Out-gassing can take up to 24 hours. Ferguson has found this often isn’t a problem for tubing manufacturers. “In most applications, this is an intermediate step. You’re doing more to the component than just assembling the tubing, so it will de-gas while you’re performing other tasks.”

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Swellex reduces the amount of force needed to insert a tube onto a barb or other type of connector.

Image courtesy of MicroCare Medical

• Swellex is flammable, but medical tubing manufacturers generally only use about a liter at a time.

“It’s no more of a challenge than having a little bit of IPA,” Ferguson said.

• The fluid does pull some oils out of the skin. The recommendation is that workers wear gloves when assembling tubing.

Overall, Swellex has been a best-seller for MicroCare. “After qualifying Swellex and seeing how it can speed assembly and throughput, many companies recommend it for their other divisions, Ferguson said. “Swellex is rapidly expanding throughout the medical manufacturing industry.” M

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VALIDATION

How to streamline sterile package validation The requirements for validating the back-end processes for packaging, manufacturing, sterilization and shelf life of a sterile medical device are often misunderstood.

I

t can take nearly a year to get a validated sterile package to market, and many medical device manufacturers fail to plan for this time and expense. While regulations govern package design and validation, manufacturers must also coordinate compliance with additional regulations for manufacturing, sterilization and shelf-life validation to reduce lead time, improve quality and reduce costs.

Here’s an explanation of how to coordinate these validation requirements to get single-use medical devices to market faster and less expensively.

Key regulations Medical device OEMs typically work with three separate entities for the back-end stages of product realization: contract manufacturers, testing labs and sterilization companies.

These entities often focus on their particular expertise without helping the OEM navigate the entire process. The best way to think about the market launch requirements of sterilized, single-use medical devices is to think in terms of how these requirements work together.

Package design Package design is regulated by ISO 11607 (Parts 1 and 2), which requires that sterile packaging be treated as a system that combines the sterile barrier and external protective packaging to deliver the device from manufacturing to the sterile field.

This requires a significant amount of design, verification and validation as well as an understanding of the stresses the package will endure throughout the distribution cycle.

This standard includes some critical steps, including:

Image courtesy of J-Pac Medical

Jeff Barrett | J-Pac Medical |

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• Developing packaging system requirements that specify the customer’s design needs. Requirements include the sterile barrier and the protective packaging system.

Medtech manufacturers must obtain customer feedback on package ease-of-use and understand the device’s storage, transportation and shelf-life requirements. Other considerations include the requirements for the microbial barrier and possible interactions of the sterilization method with the sterile barrier and the device itself.

• Designing a sterile barrier. These may include porous and nonporous pouches, headers, patch bags and thermoformed trays. The packaging solution is a direct result of the system requirements. www.medicaldesignandoutsourcing.com

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VALIDATION

• Designing protective packaging.

Packages often fail when manufacturers don’t consider shipping methods. For example, products shipped on pallets must be tested to ensure they can be delivered through sterilization, but further testing is required if those pallets are broken down and the products are shipped on common carriers. Consolidated shipping configurations must also be considered. Orthopedic implants, in particular, generate significant stresses on packaging and are highly sensitive to shipping configurations.

• Package prototyping is recommended.

It ensures the final package will meet customer needs and work for the product. Contract manufacturers with internal thermoforming and an array of packaging technologies can provide a realistic sample of the final package much faster than having to coordinate multiple suppliers.

• Package verification testing typically includes peel testing and bubble-leak testing. It’s important to validate such tests in advance. Some labs report up to 30% of their medical device packages fail the ASTM or ISTA transit tests.

• It’s important to conduct a sterile presentation test with end-users.

The test ensures the device can be aseptically presented. Some packages allow the device to gently fall onto a sterile table while others require manual removal. Each scenario affects design for ease of opening.

Validation of forming, sealing and package assembly The process used to assemble the package and seal the sterile barrier must be validated. Key steps include: • Developing a sampling plan that applies to the process being validated based on a statistically valid rationale.

ISO 2859-1 or ISO 186 are common references.

• Using a validated test method and defining the criteria for acceptance.

• Installation Qualification (IQ) of tooling design and fabrication for forming and sealing equipment.

• Operational Qualification (OQ) of the sealing process to ensure that a seal made under the worst-case process variation will stay intact. Packaging produced for subsequent sterilization 44

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Images courtesy of J-Pac Medical

and transit testing must be produced at OQ-low to simulate worst-case manufacturing conditions.

• Process Qualification (PQ), which involves producing packaging under real-world manufacturing conditions, including multiple shifts and operators.

Manufacturing process validation A separate IQ, OQ, and PQ must be performed for the assembly process before sterilization validation. Conducting the production and assembly process validation in conjunction with package validation saves significant time.

Worst-case sterilization Because sterilization can harm a medical device package and reduce device shelf life, the package must be exposed to justified worst-case sterilization before

transit testing. A double sterilization cycle can simulate worst-case. The contract manufacturer should work with the sterilizer to determine the best assumptions.

Transit testing Transit testing has two goals: to evaluate whether device interaction with the package during shipping will compromise the sterile barrier or the product itself, and if sterilization will affect the sterile barrier regardless of the product interaction.

Select the ISTA or ASTM transit test that best reflects the actual transportation and storage environment that the package will undergo, including humidity, temperature, compression, vibration and shock. Testing for both palletized movement and individual shipper handling is crucial.

ISO 11607 requires proper documentation and a rationale for the use of a particular test along with detailed conditions under which the sterile barrier must be maintained.

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Seal testing Always conduct seal tests with empty packages to evaluate the effects of sterilization alone — and not the device — on the package. Seal tests are performed after both accelerated and real-time stability testing. The FDA will accept accelerated shelf-life testing as long as real-time testing is completed in parallel. The desired shelf life dramatically affects the cost of the test due to the sample size and test time required.

Accelerated shelf-life testing allows the product to be launched more quickly and can be critical to supporting clinical trials.

Sterilization validation There are two main methods to validate sterilization. First is validating the desired load size for ongoing production. This method requires that the planned batch size be validated as a whole. For example, a fourpallet ethylene oxide chamber process can be validated with four pallets of packaged product or a smaller amount of packaged product with dunnage that simulates the

density of the larger load. This can be an impractical method for new product launches because it often requires more product to be produced than needed for market launch.

The second popular method is “single lot release,” in which three separate smaller lots of product are sterilized, followed by a retrospective study to create a validated sterilization process. All three lots must be processed within one year’s time. This is often more expensive than validating a larger load but is often the most practical approach. Sterilization validation should use manufactured product out of PQ so that it represents product produced under a validated manufacturing process.

Timing of the complete validation process Timing and costs can vary greatly, depending on the validation strategy and the coordination of individual processes.

A medical device outsourcing partner

should provide a detailed schedule of timing and costs for various scenarios.

This timing must also be integrated into the higher-level product development plan. Customers are typically surprised by the length of this process, which often delays 510(k) submissions.

These typical weekslong lead times can be significantly reduced by selecting an outsourcing partner well-versed in all aspects of the process as well as having vertically integrated packaging and manufacturing processes. M

Stronger Together

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CH R I S N EW MAR K ER ED I TO R

THE U.S.-CHINA

Here’s what it means for medical device industry suppliers IF THE TARIFFS ACTUALLY MAKE A COUNTRY GREAT AGAIN, IT MIGHT BE MALAYSIA, VIETNAM OR COSTA RICA, GLOBAL MEDICAL DEVICE INDUSTRY SUPPLIERS SAY.

www.medicaldesignandoutsourcing.com

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THE U.S.-CHINA TRADE WAR is certainly affecting where U.S. medical device companies decide to make their products.

But don’t expect a bunch of manufacturing to come back to the United States.

“They are looking at what I would call ‘right-shoring,’” Freudenberg Medical CEO Max Kley said of his company’s medtech customers. For 12 years, Freudenberg (Carpinteria, Calif.) has had a plant in Shenzhen, China, just outside Hong Kong, where about 150 workers are engaged in thermoplastic and silicone injection molding and assembly of finished devices.

With tariffs on both sides apparently here to stay, medical device customers are adjusting their supply chains, but it’s more about shifting manufacturing to other low-labor-cost locations such as Malaysia, Thailand, Vietnam, Costa Rica or Mexico, Kley told Medical Design & Outsourcing.

“It’s not necessarily moving them back to the United States,” Kley told us.

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THE U.S.-CHINA TRADE WAR

“What we are seeing is customers really looking at what they want to do with their supply chain,” said Charlie Mason, SVP of the medical division at Sanmina (San Jose, Calif.). “For next products, where do they want to be? And they're doing that evaluation.” Sanmina has an FDA-registered facility in Kushnan, outside of Shanghai, that makes complex electromechanical assemblies for medical devices. (Another plant in Shenzhen meets the ISO 13485 standard but doesn’t presently ship to the U.S.)

Haidi Li, Xingtie Deng and Shaohua Yin (left to right) are among the roughly 150 employees at Freudenberg Medical's FDA-registered operation in Shenzhen, China. The Shenzhen plant manufactures medical components in silicone and thermoplastics.

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without doing a full analysis, but those times are over, he added.

“Before customers make a decision, they're evaluating what the impact is overall — on the total cost of ownership and the return on investment. If you’re going to change, you want to drive the most value that you can,” Mason said.

And the tariffs appear to be accelerating a shift that was already taking place.

“We've talked about Thailand and Malaysia and Vietnam more in my

Image courtesy of Freudenberg Medical

circles in the last two years than we talked about them in the prior 20,” said Mark Bonifacio, of Bonifacio Consulting Services (Natick, Mass.), who advises medical device companies looking to outsource manufacturing overseas.

“Customers are examining the next most competitive footprint that would make sense. So for us, we might look at India, or we might look at Malaysia, both FDA-registered locations. For our customers, it's a matter of if they want to keep it in a particular region, go ahead and look at our alternative footprint,” Mason explained.

There was a time when medical device customers might ramp up in China

A problem that isn’t going away Under President Donald Trump, tariffs have become a go-to negotiating tactic with other countries, including close U.S. allies such as Canada and the European Union.

In late May, Trump threatened to levy them against Mexico over illegal immigration; had he followed through, it could have been a serious situation for the U.S. medtech industry as many companies increasingly manufacture south of the border.

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Customers are examining the next most competitive footprint that would make sense. So for us, we might look at India, or we might look at Malaysia, both FDA-registered locations.

But as of this writing in mid-July, perhaps no trade dispute appeared to be as deep and long-lasting as the confrontation between the world’s two largest economies.

The countries in June agreed to a truce to avoid additional tariffs, but duties on hundreds of billions of dollars worth of goods remain in place indefinitely. The U.S. medical device industry initially faced nearly $1 billion in tariffs after the Trump administration had Customs and Border Protection start collecting additional dues on goods imported from China in July 2018, trade group AdvaMed reported at the time.

In some ways, though, medical device companies are a bit lucky because they were later to the game than, say, consumer or electronics companies when it came to outsourcing manufacturing to countries with low labor costs such as China, according to Freudenberg’s Kley.

“That means that many of those decisions can still be made or can be made with a broader horizon than just cost,” he said.

Medical device companies have also had some success obtaining relief from U.S. tariffs on goods made in China. The U.S. in July exempted several categories of medical devices from the 25% tariffs, including surgical, radiotherapy and dental devices.

Medtech manufacturing in China is here to stay Despite the tariffs, a lot is going right when it comes to manufacturing medical devices in China, according to Bonifacio.

Wage increases, dictated regionally by

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THE U.S.-CHINA TRADE WAR

government authorities, have slowed down. Bonifacio has noted more favorable tax treatments for small business and manufacturers, and the Chinese government is encouraging the creation of new manufacturing locations — farther out from Shanghai, for example.

Bonifacio has found that the government’s push to teach English in schools has reduced the language barrier over the years, especially when he’s interacting with younger people. The infrastructure in China is impressive, and Chinese plants are rapidly expanding their use of robotics in manufacturing, he noted.

As Chinese companies create their own intellectual property, the government has become more serious about enforcing IP protections too, Bonifacio said. “They’ve absolutely gotten better. Anyone who does manufacturing in China will tell you that.

Now are they perfect? No. But they have

This is where we see the market opportunity, because that's where many existing manufacturers in China do not have the technology, or they do not have the trained associates, and they don't have the quality system to really cater to these demanding applications. to make a government commitment to make sure that they improve on that.”

Medical device companies are also increasingly manufacturing in China for China, as the country’s middle class expands and demands higher-quality healthcare.

Mason at Sanmina has seen customers talking about pulling some products destined for the U.S. out of China — at the same time that they’re

talking about ramping up manufacturing of products sold in China.

Kley at Freudenberg has also noticed a shift in the company’s Chinese production toward helping medtech companies create sophisticated devices destined for the local market.

“This is where we see the market opportunity, because that's where many existing manufacturers in China do not

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s.

on

THE U.S.-CHINA TRADE WAR

have the technology, or they do not have the trained associates, and they don't have the quality system to really cater to these demanding applications,” Kley said.

“There is room to play at the top end, the more demanding end of the market.”

“If you are a multinational medical device player, I don't think you can afford to miss out on the growth opportunities offered in China or the Asia Pacific medtech markets,” he said.

A case for reshoring?

Tariffs, however, are strengthening the case for manufacturing in the U.S., said Dennis Vetrano, sales & business development manager at Lockheed Martin’s Polaris Contract Manufacturing business (Marion, Mass.).

Polaris, which provides electronic contract manufacturing for medical and other industries, has seen some interest from a variety of customers about manufacturing more printed circuit boards in the U.S. versus overseas.

“I think some device manufacturers have found out the hard way, that the cost savings can come with multiple issues of which the most significant is a major delay in delivery, causing a halt in the products manufacturing,” Vetrano said.

Vetrano listed a host of reasons why it makes more sense than ever to make medical devices in the United States, including better IP protection, better control over external forces and less language barriers.

“There's been a better understanding that medical device manufacturers need to take a better look at total cost of ownership in understanding the struggles that can go on by having the brains of your electronic device (PCB) produced elsewhere, out of the U.S.” M

Sanmina has an FDAregistered facility in Kushnan, outside Shanghai, that makes complex electromechanical assemblies for medical devices.

Image courtesy of Sanmina

www.medicaldesignandoutsourcing.com

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Engaged B E C O M E

I think some device manufacturers have found out the hard way, that the cost savings can come with multiple issues of which the most significant is a major delay in delivery, causing a halt in the products manufacturing.

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medical device

industry supplier innovations

you need to know

Medical device innovation doesn’t just come from startups or big corporate R&D departments. Contract manufacturers and suppliers are increasingly playing a role, too.

NA NC Y C R OTTI S ENIO R ED ITO R

LONG GONE ARE THE DAYS when medical device industry suppliers simply produced or manufactured according to specifications.

Companies are increasingly coming up with their own answers to potential design and manufacturing challenges — enabling medtech innovation in the process.

From two-component injection molding to greatly improved tube extrusion monitoring, here are eight medical device industry supplier innovations that caught the attention of Medical Design & Outsourcing’s editors this year.

TRELLEBORG:

Two-component injection molding Swedish company Trelleborg developed an advanced two-component injection technology to produce complex, highprecision parts for medical devices.

The fully automated, 2K molding process allows the injection of two dissimilar silicones or a siliconethermoplastics combination in two shots

Trelleborg invented a new molding process for precision medical device parts.

Image from Trelleborg

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into a single tool. It offers medtech companies broader design latitude and eliminates the need for secondary handling and assembly operations, according to Trelleborg. The process may be used for multiple-component devices or complete ones, according to Ursula Nollenberger, product line director of

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TOP SUPPLIER INNOVATIONS

Trelleborg Sealing Solutions’ Global Elastomers Operations.

“It’s a growing trend that we’re seeing, where it’s a matter of combining multiple materials, multiple components, multiple functions,” Nollenberger told Medical Design & Outsourcing.

“Device makers are looking to combine into one composite, solid, fullybonded device versus the alternative, which a lot of times you have several components and you put them together in an assembly," Nollenberger said.

The process is especially well-suited to devices that must be small enough to fit inside wearables or long-term implants such as pacemaker micropumps, she added.

“We’re helping designers to be able to come up with solutions to nearimpossible problems in terms of intricacy of shape, size of shape, especially with this trend of devices becoming smaller and smaller,” Nollenberger said. “For patients, I think it’s more freedom. It’s about the reliability of the devices that they’re in contact with.”

3M:

A medical adhesive that allows a variety of backings 3M added an extended-wear medical transfer adhesive that allows medtech design engineers to use a variety of backings.

Company studies show that medical transfer adhesive 4075 offers up to 14-day wear time, depending on the backing material used. It meets requirements for use on intact skin and has been tested to ISO:10993-5 and ISO:10993-10, which assess in-vitro cytotoxicity and a product’s potential to produce irritation and skin sensitization, respectively, according to 3M. The new adhesive is also compatible with ethylene oxide sterilization.

“It’s unique that it allows the design engineers to use the backing of their choice to meet their specific design needs,” 3M Medical Solutions division VP Marcello Napol said of the new adhesive.

“We encourage people to connect with

us and work with us specifically in what they’re trying to accomplish and what their desired outcomes are.”

Medical transfer adhesive 4075 is the latest in a series of specialty medical adhesives in 3M’s extended-wear portfolio.

The company introduced medical tapes 4077 last year and 4076 in 2017 specifically for use with wearable devices such as continuous glucose monitors.

“With this third arm of the family, we were trying to anticipate the unknowns,” Napol said. “We don’t understand the end-use cases because literally, we can’t be at the table with everyone. … We could come up with multiple backings to fit different applications but this allows the end partner to choose their backing.

This is a way for us to capture a broader audience with a more flexible design.”

3M's new 4075 medical tape can be used with different backings.

Image from 3M

Nikomed USA developed recyclable wires and reusable connectors for electrodes.

Image from Nikomed USA

NIKOMED USA:

Recyclable wires for patient monitors and ECG electrodes Nikomed USA launched a non-metal, disposable and universal lead wire system for patient-monitoring equipment and ECG electrodes.

Many health providers find metal lead disposal challenging because they

can’t recycle the material, according to Nikomed USA (Hatboro, Pa.). The company designed BioWire to be recyclable; it’s made of polyethylene terephthalate (PET) and silver ink.

PET is light, flexible and strong, www.medicaldesignandoutsourcing.com

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TOP SUPPLIER INNOVATIONS

and silver ink is conductive and bonds well with PET, Nikomed USA president Steve Epstein told MDO. The company adds chloride to the silver to match the AAMI standard for ECG electrodes and lead wires because chloride prevents polarization of contacts after defibrillation.

BioWire can easily adapt to most monitoring equipment and all ECG electrodes. Its ribbon-like design makes it possible to write on or apply a label to the wiring itself, according to the

company. Healthcare customers’ desire for disposable wires has led to an issue with waste, Epstein added.

“There’s miles and miles of metal wire being discarded every day,” he said. “I said, ‘There’s got to be a better solution.’”

BioWire may also reduce the likelihood that disposable wires are reused from patient to patient, preventing cross-contamination and improving the bottom line for customers, Epstein told us. Nikomed sells exclusively through medical supply distributors.

FREUDENBERG MEDICAL:

Taking tube extrusion monitoring to a new level

Freudenberg Medical multi-lumen silicone tubes Image from Freudenberg Medical

Freudenberg Medical developed technology that the company says can help ensure uniform geometries of its silicone tubing. The Vigeo platform uses tomographic sensors to deliver a crosssection view of the product, including the tube’s inner geometry, which was not possible using traditional laser sensor-based inline measurement systems. The industry standard for laser sensor inline systems requires inline measurement of the outer geometry, but this does not provide any information on the inner geometry of the tube (ID or multi-lumen). Quality checks for the inner geometries have traditionally been made in an off-line process by manual cuts at discrete cross sections of a tube.

Vigeo’s sensors obtain measurement values that are displayed, documented and calculated by an algorithm, stitching together the pictures each sensor provide into one cross-section view. That view provides an accurate and continuous read of inner and outer geometries and tubing wall thickness during a complete production run, according to Freudenberg.

Critical medical devices such as pacemaker leads and silicone tubing for pumps may benefit the most from this level of control and documentation of every dimension throughout the entire production run and not only on a sample basis, the company said.

Having full documentation of measurement data may reduce customers’ incoming inspection routines, as well as their validation efforts, speeding time to market, Freudenberg said. The company has begun using Vigeo in its Kaiserslautern, Germany, facility, with plans to introduce it into one of its U.S. plants.

“The company started using it two to three months ago, said Kai Opdenwinkel, general manager of the Kaiserslautern plant, told MDO. “We’re quite satisfied with what we see right now.”

There’s no reliable data yet on how much waste the technology allows Freudenberg to save. “For now I think the bigger benefit is to tell the customer, ‘Ok, we monitor every single inch we extrude of your tube,’” Opdenwinkel said.

The company started using it two to three months ago. We're quite satisfied with what we see right now.

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COVESTRO:

A raw material for wound dressings and wearables Covestro recently featured its Baymedix FD103 water-based polyurethane dispersion material at MD&M East as a raw material for wound dressings and long-term wearable medical devices such as continuous glucose monitors and heart monitors.

Baymedix FD103 may be used to make roll stock for medical foams, adhesives and films. Covestro suspends polyurethane particles in water until the mixture reaches a consistent form, according to Bentley Mah, senior technical sales specialist.

“Part of our proprietary technology is keeping it in that suspension so it doesn’t settle out,” Mah said. “That helps with the manufacturability.”

Foam made from Baymedix FD103 is thermoformable, allowing for design

flexibility for wearables and dressings.

Medtech manufacturers may also embed sensors or other electronics within the foam, which provides temperature and damage insulation. The waterborne suspension also allows thinness, flexibility and moisture management in the finished product.

“They are very, very breathable materials,” Mah said. “For wound care, having that fine balance of having a moist wound bed and having that breathability, it allows it to heal. This is well researched.

With our materials, you can customize the breathability.”

Medical foams made from Baymedix FD103 pull exudate away from wounds and absorb the fluids to aid healing, Mah added.

Manufacturers can easily add antimicrobials

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and other healing agents, he said.

Covestro makes raw materials for several industries and adjusted its processes to meet tough medtech industry standards in formulating Baymedix FD103.

“We understood the design and quality and change-management systems for the

medical design industry,” Mah said. “It was kind of adapting off our own internal quality systems, at least for the medical side, to fit what the medical OEMs or the medical device manufacturers needed so they can simply plug in and say that this product can be used for medical applications.”

TELEFLEX MEDICAL OEM:

A braiding process that enables complex suture designs

Teleflex Medical OEM developed an innovative manufacturing process for braid sutures that met customer expectations for strength and the ability to customize multiple configurations.

Image from Teleflex Medical OEM

PTFE spray booths for discrete components Contract manufacturing giant Integer Holdings can now do high-volume, discrete component polytetrafluoroethylene (PTFE) spray coating, thanks to new spray booths it has developed. The Plano, Texas–based company developed and qualified the programmable and automated dry

Image courtesy of Integer Holdings

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anchor and the split, or with a fixation button where the suture could be threaded through the furcation segment to create a loop,” said Jim McCormack, Teleflex Medical OEM’s global marketing manager, in an email to MDO. The company’s challenge was to develop an innovative manufacturing process for braids that met customer expectations for strength and the ability to customize multiple configurations.

The bi/tri/quad furcated braids give OEM customers the ability to customize advanced configurations for applications in which a single suture segment might not have worked in the past.

“Furcated-braid suture has potential to be used for orthopedic applications, specifically knee, foot and ankle, shoulder, and elbow,” McCormack said. “An additional potential application could be as a component in manufacturing devices, such as artificial heart valves. The loop within the braid makes it convenient to create a knotless loop.”

INTEGER HOLDINGS:

Integer Holdings developed and qualified programmable and automated dry filter electrostatic spray booths.

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Teleflex Medical OEM recently announced an advanced braiding technology that can divide a suture into multiple end branches or integrate several “loops” within the strand.

The process can produce variations of complex, divided segments at the end of a suture, or between singular round or flat-tape segments. It eliminates the need for expensive and time-intensive manual sewing, according to the Gurnee, Ill.–based company. It also allows for a range of configurations that the company expects will to be used in orthopedic applications that currently require two sutures for fixation.

Teleflex Medical OEM can use the furcated braiding process to customize its high-strength Force Fiber OrthoTape braid, a flat tape, as well as its Force Fiber Fusion suture, which transitions from round suture to a flat center and back to round suture in one strand.

“There is potential to use the furcated product with anchor devices where the singular segment would be used with the

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filter electrostatic spray booths with reciprocating spray heads. The spray booths can accommodate discrete medical components, subassemblies and devices.

The spray booths have computer controls for critical processes, including spray pattern, spray duration and curing time. Each product is loaded into a fixture

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and attached to a speed-controlled conveyor system. The highly repeatable process yields optimal adhesion and durability, and allows for flexible coating processes, depending on the application, according to Integer.

Integer’s customers were seeking a reliable, high quality, vertically integrated PTFE spray coating supplier that could produce efficiently and in high volumes, according to Andrew Senn, Integer’s VP of marketing.

Devices that could benefit from this capability include guidewires, core wires, coated hypotubes, stylets, pull

wires, delivery systems and catheter mandrels. The coating technology enables consistent, high-quality, high-performance, and efficient products and components, according to Integer.

“High-quality devices contribute to patient safety, and consistent coatings lead to predictable, reliable device performance for physicians and patients,” Senn said.

High-quality devices contribute to patient safety and consistent coatings lead to predictable, reliable device performance for physicians and patients.

HERRMANN ULTRASONICS:

Improving ultrasonic assembly Herrmann Ultrasonics’ HiQ Dialog medical device manufacturing system is designed to increase manufacturing efficiency through optimized cycle time, changeover and downtime — three factors that affect manufacturing efficiency.

HiQ Dialog has programmable stroke selection and a “SoftTouch” mode that reduces damage to sensitive joints. Its quick-change system and hinged toolchange cover can quickly mount an ultrasonic stack in less than a minute, according to the company.

The amount of force applied to a part during the weld cycle is a critical process parameter, according to Michael Lindsay, a Herrmann Ultrasonics applications engineer. The ability to vary the forces throughout the cycle allows for more precise control of the collapse rate while compressing both halves of the welded assembly together.

An optimized rate of collapse can affect the final outcome of the welded assembly, especially in weld strength and appearance, Lindsay told MDO.

“With traditional pneumatically driven systems, there are limitations to varying the forces throughout the stroke of an air cylinder,” he said. “Our goal was to engineer a solution that has the capability of forceprofiling throughout the weld, allowing you to refine the process for an optimized result.”

The HiQ Dialog’s force profiling capability allows a medtech manufacturer to refine its weld parameters to a level that’s closer to the middle of the potential process window. This reduces the risk of a bad weld, creates a higher yield and may improve efficiency by reducing machine cycle time. The HiQ Dialog also has position control, allowing a manufacturer to set an intermediate start position so the cylinder does not have to travel all the way back to the fully retracted home position after each weld.

“Combine that feature with the ability to maximize the ‘free air’ travel speed to and from the part before and after the weld, and now you have the capability to significantly reduce your overall machine cycle time,” Lindsay said. M www.medicaldesignandoutsourcing.com

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Herrmann Ultrasonics’ HiQ Dialog medtech manufacturing system Image courtesy of Herrmann Ultrasonics

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C H R IS N E W M AR K ER E D ITO R

TOP10

The

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medical device states California, Minnesota and Massachusetts dominate the U.S. medical device industry.

But many other states also play a significant role in medtech.

CALIFORNIA Medical device industry employment (2017): 69,464 Medical device industry establishments (2017): 2,037 Major medical device company headquarters (2018): 15 Medical device patents (2015): 3,189 Medical device VC investments (2018): $1.613B Medical device VC deals (2018): 76 Best States for Business ranking (2018): 29 DESPITE COMPLAINTS about the high costs of doing business, California is unrivaled when it comes to the size of its medical device industry — not to mention the range of innovations. From medtech employment to patent numbers to the amount of venture capital investment, California is well ahead of other states. It accounted for nearly a fourth of the U.S. medical device industry’s revenue in 2017, according to IBISWorld.

The Golden State’s medical device industry is actually made up of a number of major hubs running the length of the state:

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FROM INDUSTRY EMPLOYMENT to venture capital investment to notable industry suppliers, read on and discover how the medical device industry's top states compare.

North Bay The North Bay region outside San Francisco is an important medical device manufacturing hub. Two of Medtronic’s business units — Aortic and Peripheral Disease Management and Coronary and Structural Heart Disease Management — are based in Santa Rosa.

Silicon Valley Silicon Valley includes the dominant player in robotic surgery, Sunnyvale-based Intuitive Surgical.

Cancer treatment innovator Varian Medical Systems is headquartered in Palo Alto, and invisible, customized orthodontics maker Align Technology is based in San Jose.

Mobile and digital health remain hot areas for the high-tech industry, with 505 digital health and 620 wearables exhibitors at this year’s CES show in Las Vegas. Cooperation between medical device companies and consumer technology companies, including Apple and Google’s life sciences sister company Verily, is increasing as more products roll out to monitor people’s health and catch problems early.

The region is also home to Carbon, a major 3D printing innovator that is forging partnerships with medical device companies including Johnson & Johnson and BD. In Milpitas, upstart Bigfoot Biomedical has a partnership with Abbott as it seeks to create an improved automated insulin delivery system for diabetes treatment. The Fogarty Institute for medical device innovation is based in Mountain View.

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Orange County Orange County exported more than $4 billion worth of life science exports in 2015 alone — about three-fourths involving medical device and diagnostic equipment shipments, according to trade group Biocom. The medtech industry in the county as of 2016 included 23,673 workers, a headcount larger than most U.S. states' medical device workforces.

The hundreds of firms in the county include Irvine-based Edwards Lifesciences, a major player in the cardiovascular devices space, and San Clemente-based ICU Medical, provider of IV-based therapies, systems and services. Johnson & Johnson's vision surgical business, formerly part of Abbott, is based in Santa Ana. Besides Biocom, local industry boosters include OCTANe and the Device Alliance.

The Alfred E. Mann Foundation for Scientific Research is based nearby in Valencia, and Medtronic’s diabetes

business is based in the Northridge section of Los Angeles.

San Diego San Diego is home to a number of companies pushing the boundaries when it comes to packaging digital health with medical devices, including Dexcom and its continuous glucose monitoring systems for diabetes management and ResMed and its CPAP equipment for treating sleep-related breathing disorders. Spine technology company NuVasive is also based there.

The medical device industry in San Diego County employed 9,770 people at 211 companies as of 2016, according to Biocom.

Notable medical device industry suppliers Freudenberg Medical (Carpinteria) boasts technical capabilities ranging from the design and manufacture of minimally invasive, catheter

MINNESOTA Medical device industry employment (2017): 30,500 Medical device industry establishments (2017): 470 Major medical device company headquarters (2018): 4 Medical device patents (2015): 991 Medical device VC investments (2018): $260M Medical device VC deals (2018): 16 Best States for Business ranking (2018): 10

Photo by Nicole Harrington on Unsplash

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and handheld technology to the development and production of medical components through advanced materials and processes.

Green Hills Software (Santa Barbara) says its products allow for faster medical device development.

Flex (Singapore; U.S. Headquarters in San Jose) offers design, engineering, manufacturing, real-time supply chain insight and logistics services.

IDEX Health & Science (Rohnert Park) focuses on advanced optofluidic technologies.

Medical Extrusion Technologies (Murrieta) has been providing custom medical tubing extrusions for more than 20 years.

Traco Power North America (San Jose) provides customers with optimal power supply solutions.

Wright Engineered Plastics (Santa Rosa) is a San Francisco Bay Area plastic injection molder and contract manufacturer.

MINNESOTA ARGUABLY has the institutions and the talent required to provide the U.S. healthcare industry the innovation it desperately needs. The question is whether potential investors will notice the hub nicknamed “Medical Alley.”

One of the nation’s top health providers, Mayo Clinic, is based in Rochester. One of the largest health insurers in the U.S., UnitedHealth Group, is based in Minnetonka, with its Optum subsidiary seeking to combine technology, data and expertise to improve healthcare delivery.

And one of the world’s largest advanced manufacturing and medical device companies, 3M Co., is headquartered in Maplewood.

The Minnesota medical device hub’s roots go back to the middle of the 20th century, when University of Minnesota surgeons including Dr. C. Walton Lillehei pioneered open-heart surgery.

Lillehei happened to meet Earl Bakken, who along with brother-in-law Palmer Hermundslie had started a business out of a garage repairing hospital equipment. Lillehei tasked Bakken with finding a replacement for the large, unreliable pacemakers then in use. Bakken and Hermundslie’s business eventually grew into Fridley, Minn.–based Medtronic — now the world’s largest medical device company.

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Manny Villafaña, a Bronx native who came to the Twin Cities decades ago, started out in the 1960s working on international sales for Medtronic. But he then took a risk and founded Cardiac Pacemakers Inc., which is now part of Boston Scientific’s Guidant business. Boston Sci continues to have a large presence in the Twin Cities.

By the mid-1970s, Villafaña wanted to innovate in another area: Bileaflet mechanical heart valves. The resulting company was St. Jude Medical, which Abbott acquired for $25 billion in 2018. (Villafaña, now in his 70s, remains an active entrepreneur.)

Beyond the several well-known medical device companies with large presences in Minnesota — Medtronic, Boston Scientific, Abbott, and Smiths Medical — Minnesota boasts a vast ecosystem of contract manufacturers, device testing outfits, designers, and regulatory and product development consultants to support the industry. It employed 30,500 Minnesotans in 2017, according to the Minnesota Department of Employment & Economic Development.

The University of Minnesota has a Medical Devices Center, and the Medical Alley Association is the top industry booster in the state.

Notable medical device industry suppliers 3M (Maplewood) not only sells an array of medical and surgical supplies and drug delivery systems but is also a major supplier of medical adhesives for a variety of devices.

Ametek Engineered Medical Component boasts design and manufacturing capabilities including custom engineered interconnects, catheter components and systems, implanted lead components, ultrasound assemblies, and precision laser machining services.

Cirtec Medical (Brooklyn Park) has more than 30 years of experience developing medical devices fabricated under 21 CFR 820 and ISO 13485 quality standards.

It specializes in technologies ranging from ventricular assist to cardiac rhythm management to implantable drug delivery.

CPC (Colder Products Co.) is a St. Paul-based provider of quick disconnect couplings, fittings and connectors for plastic tubing.

Creganna Medical — a TE Connectivity company with a focus on minimally invasive delivery and access devices — has three offices west of Minneapolis.

Donatelle (New Brighton) specializes in complex applications where precision, tolerances and validation are critical.

Heraeus Medical Components (St. Paul) draws on the global resources of its German parent company to provide materials, components, assemblies and accessory devices for active devices.

Heraeus also provides interventional product assembly, components and finished sterile device expertise from design through manufacturing.

Integer, which includes the former

Lake Region Medical, has a major presence.

Lowell (Brooklyn Park) manufactures complex medical devices for the orthopedic and cardiovascular markets.

Minnesota Rubber and Plastics (Plymouth) designs, develops and manufactures rubber, plastic and silicone components, assemblies and finished product.

Minnetronix (St. Paul) since 1996 has been a development, manufacturing and technology partner for medical device companies around the world.

Nortech Systems (Maple Grove) is able to provide combine wire/cable, PCBA, and a number of value-added manufacturing services in an FDAregistered facility. Nortech also has Devicix, its world-class engineering services group.

Phillips-Medisize — one of the largest medical device contract manufacturers in the world — is based over the St. Croix River in Hudson, Wis. ProMed Molded Products in Plymouth is marking its 30th anniversary this year.

Protolabs is a rapidly growing "digital manufacturer" with a variety of fast manufacturing processes that have made medical-related products ranging from fitness trackers to a blood-clotdetecting ultrasound system to earcleaning headphones.

Switchback Medical (Maple Grove) provides device prototyping, development and full program management.

MASSACHUSETTS MASSACHUSETTS MAY NOT have the medical device industry employment levels of some states. But it still deserves to be among the top three medtech states because of its large number of major company headquarters and the hundreds of millions of public and private dollars annually spent on innovation.

The Bay State is a medical research powerhouse.

Its top research hospitals are among the best in the nation: Mass General, Brigham & Women’s, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston Children’s, the University of Massachusetts Medical School, and Dana Farber. In 2018 alone, these seven institutions secured thousands of NIH awards totaling $2.89 billion — up from $2.7 billion a year before, according to a Grant Thornton report prepared for trade group MassMEDIC.

Medical device industry employment (2017): 14,895 Medical device industry establishments (2017): 309 Major medical device company headquarters (2018): 7 Medical device patents (2015): 810 Medical device VC investments (2018): $499M Medical device VC deals (2018): 23 Best States for Business ranking (2018): 19

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Add in $499 million in medical device venture capital and headquarters of companies including Boston Scientific, Hologic, Bruker, Haemonetics, Abiomed, Insulet and NxStage Medical, and it’s little wonder that Grant Thornton found that Massachusetts leads on PMAs and 510(k) clearances when the numbers are adjusted for the size of state GDP. Nearly a quarter of Massachusetts' exports involve medical devices, a larger portion than any other state, according to Grant Thornton.

Notable medical device industry suppliers Eagle Stainless Tube & Fabrication (Franklin) specializes in fabricated products in stainless steel, nickel alloys, aluminum and titanium — including ultra-high precision, cut-to-length, stainless steel tube & bar.

Freudenberg Medical announced last year that its headquarters would be located at a new facility in Beverly.

Maxon Motor (Taunton) provides precision drives for insulin pumps, prostheses, active implants and more.

Software company PTC is in Boston.

Resonetics — a laser micro manufacturer — has a facility in Nashua, N.H.; Tecomet (Wilmington) specializes

Photo by Osman Rana on Unsplash

in forged, cast and machined orthopedic implants, precision surgical instruments, sterilization cases/trays and photochemical etched products.

Tegra Medical (Franklin) produces components and complete devices for surgical and interventional companies.

Offerings range from prototyping to full production, and from components to finished medical devices.

Tecomet (Wilmington) serves a variety of medical markets ranging from ortho to cardio.

Testing outfit Toxikon is in Bedford.

Viant (previously MedPlast and Integer Advanced Surgical & Orthopedics) announced last year that it was moving its headquarters to Foxborough.

Design outfit Ximedica is based nearby in Providence, R.I.

FLORIDA Medical device industry employment (2017): 23,571 Medical device industry establishments (2017): 1,275 Major medical device company headquarters (2018): 1 Medical device patents (2015): 437 Medical device VC investments (2018): NA Medical device VC deals (2018): NA Best States for Business ranking (2018): 7

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FLORIDA IS AMONG the top states when it comes to the number of FDA-registered medical device manufacturing facilities, according to the public-private partnership Enterprise Florida. The majority of companies are located along the Interstate 4 corridor in Central Florida, the Jacksonville area and in South Florida.

Biotech, pharmaceutical and medical device companies with presences in the state include Actavis, Arthrex, Bristol-Myers Squibb, Johnson & Johnson, Medtronic, Noven and Steripak.

Medtronic Surgical Technologies is based in Jacksonville, and RTI Surgical is headquartered in Alachua.

Notable medical device industry suppliers MicroLumen (Oldsmar) is an international manufacturer of polyimide medical and surgical tubing.

Spectrum Plastics Group, headquartered next door in Alpharetta, Ga., develops and makes specialty medical plastic products.

Zeus, a major innovator in the medical tubing space, is headquartered to the north in Orangeburg, S.C.

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INDIANA WARSAW, IND. is nicknamed the "Orthopedic Capital of the World.” The orthopedic medical device manufacturing industry in Warsaw has roots going back to 1895, when Revra DePuy started the DePuy Manufacturing Co. to make fiber splints. The business today is Johnson & Johnson’s DePuy Synthes Co., which employs 18,000 people across 60 countries and generates $10 billion in annual sales. DePuy Synthes is still a presence in Warsaw; its joint reconstruction business is based there.

During the 20th century, DePuy competitors Zimmer and Biomet started in Warsaw. The two in 2015 merged into Zimmer Biomet, a $7.8 billion-a-year company.

In addition to the ortho industry giants, the industry in Warsaw supports a host of suppliers. Wilmington, Mass.–based contract manufacturer Tecomet, for example, has a location in the city to serve the orthopedic device industry.

Bloomington is the home of the privately held Cook Group, a maker of minimally invasive medical devices.

Medical device industry employment (2017): 18,901 Medical device industry establishments (2017): 432 Major medical device company headquarters (2018): 1 Medical device patents (2015): 428 Medical device VC investments (2018): $22M Medical device VC deals (2018): 6 Best States for Business ranking (2018): 11

Notable medical device industry suppliers Greenlight Guru (Indianapolis) has quality management software designed specifically for the medical device industry.

PENNSYLVANIA BENEFITS from its proximity to major companies headquartered in New Jersey and New York.

Take New Brunswick, N.J.–based Johnson & Johnson as an example. Its DePuy Synthes business has a number of operations based in West Chester, and the University of Pennsylvania in Philadelphia was the first location for Johnson & Johnson Innovation’s JPOD business incubators.

Teleflex is based in Wayne, Dentsply Sirona is run out of York, and B. Braun Melsungen’s B. Braun Medical business is headquartered in Bethlehem.

Notable medical device industry suppliers B. Braun’s OEM Division is an outsourcing partner for medical device and pharmaceutical companies.

Fluortek (Easton) specializes in the creation of extrusions engineered to custom requirements and unique applications.

Johnson Matthey Medical Components (West Chester) Regulatory & Quality Solutions, also known as R&Q, provides regulatory and quality consulting and engineering for medical device and combination product companies.

Photo by Gibson Hurst™ on Unsplash

PENNSYLVANIA Medical device industry employment (2017): 16,832 Medical device industry establishments (2017): 432 Major medical device company headquarters (2018): 2 Medical device patents (2015): 451 Medical device VC investments (2018): $40M Medical device VC deals (2018): 10 Best States for Business ranking (2018): 30

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Crescent Industries (New Freedom) offers 3D printing, 2D and 3D part design and mold design models, and 3D mold fill simulation and material for a wide variety of medical, dental and surgical devices.

John Evans’ Sons (Lansdale) provides

medical equipment design consisting of computer monitors in fixed and mobile applications, dental X-ray equipment articulated arms as well as medical equipment drawer closing mechanisms.

Solar Atmospheres (Souderton)

offers vacuum heat-treating services for implants, guide wires, stents, surgical tools, hypodermic tubing and device assemblies.

TE Connectivity’s U.S. headquarters are in Berwyn.

NEW YORK Medical device industry employment (2017): 14,956 Medical device industry establishments (2017): 755 Major medical device company headquarters (2018): 2 Medical device patents (2015): 427 Medical device VC investments (2018): $172M Medical device VC deals (2018): 8 Best States for Business ranking (2018): 26

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NEW YORK STATE officials have goals to give Massachusetts a run for its money as a life sciences innovation hub. Three years ago, Gov. Andrew Cuomo announced a $650 million initiative to create a new, world-class life science research cluster in the state.

Major medical device companies based in New York include Henry Schein (Melville) and ConMed (Utica).

Notable medical device industry suppliers Huron Tool & Cutter Grinding (East Farmingdale) focuses on the design, engineering and development of sophisticated surgical tools and instruments.

Autronic Plastics (Central Islip) is a plastic injection molding company that specializes in difficult-to-process engineering resins, metal replacement, and precision plastic components, including medical/dental housings, testing components, sleep apnea products, dental scalers, medication administration devices, pump components, dental imaging equipment, and camera lenses.

Currier Plastics provides design, blow molding, injection molding, design, prototyping and manufacturing for medical devices at its Auburn facility.

Hicksville-based Designatronics’ company Stock Drive Products/Sterling Instrument (SDP/SI) supplies precision components to the medical industry, including parts for robotically assisted surgery.

Huron Tool & Cutter Grinding (East Farmingdale) is an orthopedic and arthroscopic tool contract design and manufacturing company.

Brooklyn-based Lee Spring stocks millions of springs and can custom-make springs for the medtech industry.

MIDI offers product research and development services to medtech companies from its Smithtown headquarters.

Precipart (Farmingdale) provides precision components, custom gears, assemblies and systems integration for a wide breadth of medical applications.

Röchling Medical’s Rochester location offers contract manufacturing, product design and mold making, accelerated tooling, and engineering division.

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TEXAS Medical device industry employment (2017): 14,458 Medical device industry establishments (2017): 814 Major medical device company headquarters (2018): 3 Medical device patents (2015): 398 Medical device VC investments (2018): $34M Medical device VC deals (2018): 10 Photo by Vlad Busuioc on Unsplash

TEXAS HAS INCREASINGLY become an attractive place for growing medical device companies to set up shop; the Lone Star State ranks high on Forbes’ Best States for Business report.

It also helps that Houston is home to the largest medical complex in the world — the Texas Medical Center. The Texas Children’s Hospital and the MD Anderson Cancer Center are among the highly

Best States for Business ranking (2018): 3

regarded institutions based at the Texas Medical Center.

A host of medical device OEMs have facilities in the state.

Notable medical device industry suppliers AirBorn (Georgetown) has provided connectors to defense, space and medical OEMs for 60 years.

Coastal Life Technologies (San

SOME OF THE MEDICAL device industry’s largest companies — including GE Healthcare, Abbott, Baxter, and Hill-Rom — are based in or around Chicago.

Notable medical device industry suppliers Eastek International (Lake Zurich) boasts customized medical machining, abilities in precision manufactured products, and more.

Flexan (Lincolnshire) specializes in custom, high-precision silicone, rubber, and thermoplastic components and devices.

MW Industries (Rosemont) has specialized products for the medical and pharmaceutical industries, including precision wire forms and metal stampings. The company offers a wide variety of spring designs, tubular components and related product assemblies.

Teleflex Medical OEM (Gurnee) has a variety of expertise: extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/ dilator sets; specialized sutures, braids, and fibers; bioabsorbable sutures, yarns and resins; and more.

ILLINOIS Medical device industry employment (2017): 13,967 Medical device industry establishments (2017): 755 Major medical device company headquarters (2018): 4 Medical device patents (2015): 270 Medical device VC investments (2018): $50M Medical device VC deals (2018): 5 Best States for Business ranking (2018): 39

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Antonio) specializes in the assembly, packaging and sterilization of single-use surgical devices.

Integer, the largest medical device contract manufacturer in the world, is headquartered in Plano.

Millar, which provides medical device companies with sensors based on MicroElectrical Mechanical Systems (MEMS), is based in Houston.

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NEW JERSEY Medical device industry employment (2017): 13,380 Medical device industry establishments (2017): 421 Major medical device company headquarters (2018): 5 Medical device patents (2015): 429 Medical device VC investments (2018): $12M Medical device VC deals (2018): 1 Best States for Business ranking (2018): 38

Other medtech states worth mentioning They didn’t make it into our top 10 list, but the following three U.S. states also play a significant role in the medical device industry.

MICHIGAN • Medical device industry employment (2017): 12,083 • Medical device industry establishments (2017): 489 • Major medical device company headquarters (2018): 1 • Medical device patents (2015): 177 • Medical device VC investments (2018): $8M • Medical device VC deals (2018): 4 • Best States for Business ranking (2018): 31

NEW BRUNSWICK-BASED Johnson & Johnson has one of the largest medical device businesses in the world. Other major medical device companies including BD, Nipro, ConvaTec and Integra Lifesciences call the Garden State home.

Notable medical device industry suppliers Micro (Somerset) is a metal tubing maker.

Custom pump manufacturer KNF Neuberger is based in Trenton.

Chicago-based MW Industries has its Servometer business in Cedar Grove.

Specialty chemical maker Evonik has a plant in Piscataway and its North American headquarters in Parsippany.

Kahle Automation has its U.S. headquarters in Morristown. The company specializes in assembly technologies for needles, syringes, tubing, IV catheters and drug-device combination products.

certified and provides assembly, kitting, packaging, and sterilization management services for single-use disposable and reusable medical products.

Medbio (Grand Rapids) is a fullservice contract manufacturer specializing in clean room injection molding, injection mold tooling, assembly and packaging.

Packaging Compliance Labs

(Kentwood) offers packaging validation and engineering services to the healthcare industry.

UTAH • Medical device industry employment (2017): 11,437 • Medical device industry establishments (2017): 296

Stryker, the largest orthopedic device company in the world, is based in Kalamazoo, and Grand Rapids is a minimedical device manufacturing hub.

Notable medical device industry suppliers: Keystone Solutions Group (Kalamazoo) is FDA registered and ISO13485:2016 66

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Photo by Doug Zuba on Unsplash

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TOP MEDTECH STATES

• • • • •

Major medical device company headquarters (2018): 2 Medical device patents (2015): 194 Medical device VC investments (2018): $17M Medical device VC deals (2018): 6 Best States for Business ranking (2018): 2

More than 250 medical device manufacturers have operations in Utah, according to life science association BioUtah. There are homegrown companies including Biomerics, Merit Medical and Nelson Laboratories. Outside companies including BD, GE Healthcare, Edwards Lifesciences, Fresenius Medical Care, Stryker and Varex Imaging have facilities in the state.

Notable medical device industry suppliers: Nelson Laboratories (Salt Lake City) specializes in advisory and testing solutions for medical device, pharmaceutical, and tissue and biologics companies.

Biomerics (Salt Lake City) is a contract manufacturer and innovative polymer solutions provider for the medical and healthcare industries.

OHIO • Medical device industry employment (2017): 10,412 • Medical device industry establishments (2017): 360 • Major medical device company headquarters (2018): 3 • Medical device patents (2015): 534 • Medical device VC investments (2018): $18M • Medical device VC deals (2018): 8 • Best States for Business ranking (2018): 20 The Cleveland Clinic is one of the top health providers in the world, and Ohio boasts top-notch research at higher education institutions including Case Western Reserve University in Cleveland and the Ohio State University in Columbus. Battelle, the global research and development organization, is also in Columbus. Large medical device companies headquartered in the state include Cardinal Health (Dublin), AtriCure (Mason), and Invacare (Elyria).

Notable medical device industry suppliers: Kaleidoscope Innovation (Cincinnati) is a full-service design and development firm.

Motion and control technologies company Parker Hannifin is based in Cleveland.

Valtronic (Solon) creates miniaturized and high-precision complex products for medical device companies around the world. M Sources: Minnesota Department of Employment and Economic Development’s Compare Minnesota tool for industry employment and establishment numbers (2017) and medical device patent numbers (2015), PwC/CB Insights MoneyTree report for venture capital data (2018), Medical Design & Outsourcing’s Big 100 report (2018) for number of major, publicly traded medical device company headquarters, Forbes’ Best States for Business report (2018) for business friendliness ranking

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Senior Editor Nancy Crotti contributed to this article. www.medicaldesignandoutsourcing.com

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3 women in manufacturing you should know DAN I ELLE KI RSH ASSOCI AT E EDI TOR WOMEN ACCOUNT FOR NEARLY ONE-THIRD of employees in the manufacturing industry, in which men have historically held the majority of jobs, according to the U.S. Census Bureau.

That includes manufacturers and other outsourcers serving the medical device space.

The lack of diversity is more apparent farther up the corporate leadership ladder. The Equal Employment Opportunity Commission reports that only a fifth of executives, senior officers and managers in the U.S. high-tech industries are women. And according to a report from the Center for American Progress, women hold 52% of professional jobs in the U.S. but only 14.6% of CEO roles.

Here's a look at three women executives at medical device companies: 68

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ADVANCING MEDICAL CARE THROUGH THE SCIENCE OF

PRECISION METAL COMPONENTS ISO 13485 - FDA Facilities - Clean Room

Medical contract manufacturers rely on our speed and quality for these applications: • Auto-injectors • Dispensing Tips • Surgical Devices • Drug Delivery • Life support • Powered Surgical Components • Implants • Heart Pumps

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WOMEN IN MANUFACTURING

VICTORIA HOLT

President & CEO, Protolabs

Victoria Holt has been president & CEO of Protolabs (Maple Plain, Minn.), an automated 3D printing and CNC machining manufacturer, for more than five years.

Prior to joining Protolabs, Holt was the director of Waste Management for six years. She has also been the president and CEO at Spartech Corp. and senior VP of glass & fiberglass at PPG Industries.

Holt received a bachelor’s degree in chemistry from Duke University and a master of business administration from Pace University.

MDO: What first drew you to manufacturing? When did you first know you wanted to be in the industry?

Holt: I joined manufacturing immediately after graduating from Duke University with a degree in chemistry, when I joined Monsanto as a sales representative.

MDO: What are some of the barriers women face in today’s medtech manufacturing industry, if any?

Holt: I think the only barrier is in our own minds. The medtech manufacturing industry is growing and vibrant. We need to attract the best talent, and 50% of the talent out there are women.

MDO: Describe your biggest leadership challenge. How did you conquer it or resolve it, or what was the outcome?

Holt: The biggest challenge any leader has is gaining the hearts and minds of all your team members, so everyone can be aligned and pulling in the same direction with passion.

MDO: Talk about your leadership skills.

What is the most important lesson that’s guided you in your career?

Holt: I am a collaborative, teambased, people-first leader. I learned that to best lead in this way, it is critical to be authentic, willing to show my vulnerabilities and be humble. Leaders must have credibility, and to connect with people, you must be yourself.

MDO: In your opinion, what more can be done to promote greater participation of young women in the medtech industry today?

Holt: The medtech industry and manufacturing in general must continue to build its image as a high-technology, fastpaced industry that really makes a difference in the world. We must also connect with future leaders earlier in their journey, so they can prepare for a career in our industry. This often means exposure to manufacturing in elementary school through high school.

MARCIA COULSON

President, Eldon James Corporation

Marcia Coulson is the president of tubing, fittings and bag port at Eldon James (Denver).

Coulson has been with Eldon James for 31 years, since the company’s founding in 1987.

After selling real estate for 15 years, she was looking for the opportunity to sell her own products.

In 1987, she purchased a few molding machines and five molds from her mother and father and set up a small 70

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shop in Loveland, Colo. As the business grew, Coulson diversified and saw product potential in the pharmaceutical/life science sector and later in the food & beverage market.

In 2007, Eldon James’ PVC-free tubing product line was introduced, making Eldon James one of the only connectors and tubing manufacturers in the U.S. to solely produce PVCfree products. The company has since doubled in size over the last 10 years. www.medicaldesignandoutsourcing.com

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WOMEN IN MANUFACTURING

MDO: What first drew you to manufacturing? When did you first know you wanted to be in the industry?

Coulson: Real estate is a service industry, and you need to be very good at sales and customer service. I believed if I could take what I had learned from real estate and apply that to my own product line I would be successful. I grew up with manufacturing in our garage and was not intimidated by the thought of manufacturing.

MDO: What are some of the barriers women face in today’s medtech industry, if any?

Coulson: I have never felt barriers. If you know your product and you understand why the customer needs your product, you can present the facts. Once you’ve shown the industry you have what they are looking for, the doors open.

MDO: Describe your biggest leadership challenge. How did you conquer it or

resolve it, or what was the outcome?

Coulson: Finding good employees is my biggest leadership challenge. You’re only as good as the people you surround yourself with. We are expanding and the market is very tight. We continue to be very selective and only hire the best.

MDO: Talk about your leadership skills.

What is the most important lesson you have learned that has guided you in your career?

Coulson: Treat your employees and your customers well. People work with and for people they enjoy. Customers buy from companies they like.

MDO: In your opinion, what more can be done to promote greater participation of young women in the medtech industry today?

Coulson: Women naturally want to help people. We need to show them that

medtech manufacturing is playing a huge part in helping people. It’s the small accomplishments we make every day that have huge impact on the industry.

MDO: What career advice would you give to your younger self?

Coulson: Make sure you manufacture a product. If you are selling someone else’s product, you have to out-service all other salespeople. Be sure you manufacture a product you believe in and know that you manufacture the best quality and then offer the best service.

MDO: Why is it important for companies to be more inclusive and have more women in charge?

Coulson: Women often offer better customer experiences. They often soften the sales approach and make the customers more comfortable. Women are very detailoriented and multi-task better than men.

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WOMEN IN MANUFACTURING

JULIE LOGOTHETIS

President, Kahle Automation

Julie Logothetis was told from a young age that she needed to be an engineer.

Always fascinated with machines and how things worked, she never considered a career other than in manufacturing.

“I attended Villanova University and early on in the engineering program, I figured out that I maybe didn’t want to be an engineer and went on to receive a degree in economics,” Logothetis said.

“Upon graduating, I had a brief stint in the financial industry. Then I was given the opportunity to work in manufacturing at Kahle Automation. From the day I started working at Kahle, I knew I found the perfect balance.”

Logothetis has worked with Kahle Automation for 37 years, working her way up from sales to management and operations.

MDO: What first drew you to manufacturing? When did you first know you wanted to be in the industry?

Logothetis: I don’t feel that when I started working at Kahle it was a conscious decision that I wanted to be in manufacturing. It was more that I was presented with an opportunity and I took a chance.

It was easier, however, to be a woman in manufacturing working with the medtech industry at that time. I think that had I been working in a more industrial environment, it may have been more difficult to be a woman.

MDO: What are some of the barriers women face in today’s medtech industry, if any?

Logothetis: Compared to some of the other manufacturing industries, I feel that the medtech industry is very welcoming to women and always has been.

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MDO: Describe your biggest leadership challenge. How did you conquer it or resolve it, and what was the outcome?

Logothetis: Having worked in the automation industry and in particular with medtech companies for the past 37 years, the biggest challenge was and continues to be that at any initial introduction as I start to work together with new people and companies, I need to verify my position and my knowledge of the industry and Kahle. This might be an extra step that men don’t have to go through, but once we get past this, it’s business as usual.

MDO: Talk about your leadership skills.

What is the most important lesson you have learned that has guided you in your career?

Logothetis: I never judge people by their title or position. I always want to know and understand who you are by how you present yourself and what you have to contribute to any situation. I try to keep an open mind and believe that everyone has something positive to offer and we all need to work together to be successful.

MDO: In your opinion, what more can be done to promote greater participation of young women in the medtech industry today?

Logothetis: Enjoy the ride! I consider myself so fortunate to have this opportunity to work in an industry I love and to meet and work with such diverse and interesting people.

MDO: Why is it important for companies to be more inclusive and have more women in charge?

Logothetis: It is extremely important for companies to be open-minded and consider all candidates on their merit and not on their sex. As more and more women enter the workforce in the area of manufacturing, I do expect that you will see more women in charge.

Maybe it’s the economist in me. I loved statistics. I do believe that considering the percentage of men versus women in the workforce, the number of women in management should be representative. M

Logothetis: I don’t believe that the medtech industry has to do anything special to promote greater participation of women. As long as the industry treats women equally and rewards them based on educational qualifications and merit, we will see more women in our industry.

MDO: What career advice would you give to your younger self?

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DEVICETALKS

Inside Insulet's pivotal year with CEO Shacey Petrovic

Sarah Faulkner | Program Manager – D e v i c e Ta l k s |

At DeviceTalks Boston 2019, Insulet president & CEO Shacey Petrovic gave attendees a glimpse at what’s driving the diabetes tech company’s growth.

I

t’s been a busy year at Insulet.

The diabetes tech company welcomed a new CEO, launched its first new product in six years and officially opened its $200 million global headquarters – all in the first half of 2019.

That’s all the result of years of rapid growth for Insulet, chief executive Shacey Petrovic said in a keynote interview at DeviceTalks Boston in June.

The company’s customer base has doubled in the last four years to roughly 150,000 “Podders” – the self-selected

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name for people who use Insulet’s tubeless, wearable insulin delivery device, the Omnipod.

Omnipod Dash, the newest iteration of Insulet’s device, is the company’s latest attempt at making the lives of people living with diabetes simpler, according to Petrovic.

“Something common across all people living with diabetes – and all families because it’s very much a family disease – is the need to reduce burden and to simplify life,” Petrovic told attendees at DeviceTalks Boston 2019.

www.medicaldesignandoutsourcing.com

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DEVICETALKS

“It gets down to, fundamentally, who are we innovating for? How are we serving them? We’re really thinking about, how do we just make life easier?

How do we take out the friction in these systems?” she added.

The Omnipod Dash, which won 510(k) clearance from the FDA in June last year, wirelessly connects the company’s Personal Diabetes Manager with a waterproof insulin delivery device. Using blood glucose readings, the PDM calculates how much insulin should be delivered. Altogether the system connects via Bluetooth to an app on the user’s phone.

“Our vision is to enable our users to control their Pods via their cellphones.

We know it’s the number one request from our users and Dash was step one,” Petrovic said.

It gets down to, fundamentally, who are we innovating for? How are we serving them? We're really thinking about, how do we just make life easier? How do we take out the friction in these systems?

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“We have a product that is very much chosen by the consumer, and as we think about the intersection of consumer technologies, like cellphones, watches, various types of cloud computing, with medical technology, we see a tremendous opportunity to make good on our mission by reducing burden. If we could fit these devices into the way that people are living today and the devices that they’re already using today, we see that as tremendously beneficial on a number of fronts,” she added.

The next step in Insulet’s growth plan involves another new product – Omnipod Horizon.

Currently undergoing clinical trials, the Omnipod Horizon uses an algorithm to analyze continuous glucose monitoring data from Dexcom‘s CGM and automate insulin delivery. It’s Insulet’s answer to the call from users for an “artificial pancreas.”

Petrovic said she sees the potential in these systems to further reduce the burden for patients.

“If we could do it automatically for them based on their glucose trends, we have the potential to do it more accurately with less human error and certainly less human intervention – and all of this from an app securely controlled on your phone,” she said.

People living with diabetes have been asking for this kind of technology for years.

So much so that a group of them have figured out how to hack together their own automated insulin delivery systems using commercial devices.

But Petrovic underscored just how challenging it is to design and test such a sophisticated system.

“We’re adding in a mobile app, we’re adding in a sensor and we’re adding in an algorithm. So, we’re adding in a lot of complexity to the system, and we have to keep the user experience simple with all of that happening in the background.

That’s hard,” she said.

Petrovic also noted that the company has to design a system that works for everyone, not just tech-savvy users.

“You need it to be simple enough for a 2-year-old or for an 80-year-old. But you’re adding all this complexity into the system. That’s when it comes down to good design work, having foundational technologies like Omnipod and the Dexcom sensor, which are very reliable.

And it comes down to all the clinical work to refine the algorithm so that it can work

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If we could fit these devices into the way that people are living today and the devices that they're already using today, we see that as tremendously beneficial on a number of fronts. across a broad population of patients, effectively and safely,” she said.

Omnipod Horizon, which is slated to launch in 2020, is part of Insulet’s solution to what Petrovic identified as a nascent trend in the diabetes industry: consumer technology. Looking ahead, Petrovic said she sees a future in which more people will be dosing insulin directly from their phones and smartwatches.

“I think you may see the systems become more interoperable. This is a trend that the FDA has been encouraging around patients being able to select components of their system –

their preferred insulin delivery system, their preferred sensor, their preferred insulin, and maybe even their preferred algorithm in sort of plug-and-play systems,” Petrovic said.

“And I certainly think that there’s a mandate to make sure that all people have access to more technology to be able to manage their disease,” she added. “It’s one thing to be able to develop a great device, it’s another thing to make sure that it is broadly available. That comes down to cost-effectiveness and working very hard to demonstrate the clinical performance of technologies, as well.” M

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PRODUCT WORLD

Digital Light Lab launches new curing device Digital Light Lab has introduced a new product to its LED liquid-cooled curing line. The 6 in. AccuCure HighPowered LightBar system offers continuous or pulse mode of operation without the need for shutters and cool-down or warm-up times.

A wide beam aperture of 152 mm x 25 mm and optional control processes such as 4-20 mA and 0-5 V work well for UV curing in high-speed production manufacturing, according to the company. LEDs provide energy-efficient, targeted curing compared with other systems, which produce a variety of UV emission peaks and IR outputs that do not cure the product and may actually harm the substrate, the company said.

Lower operating energy and maintenance costs may offset the upfront cost of an LED system, and its curing solutions last tens of thousands of hours compared with the hundreds of hours of operation of a mercury system, according to Digital Light Lab. –NC

Florida Anodize System & Technologies receives ISO 13485:2016 certification Florida Anodize System & Technologies has received ISO 13485:2016 certification for its quality management system for medical device surface coating services.

The company’s offerings include its FAST ColourLock aluminum anodic coating, which is able to maintain its color after repeated rounds of harsh sterilizations. Color is an important aspect of human factors design, which medical device companies have increasingly turned to in order to reduce use errors. The ISO 13485:2016 certification came after a TÜV SÜD audit, according to Florida Anodize System & Technologies. –CN Florida Anodize System & Technologies Sanford, Fla. www.anodizefast.com

Digital Light Lab Knoxville, Tenn. www.digitallightlab.com

Guill introduces new 800 Series Hybrid extrusion tooling Guill (West Warwick, R.I.) recently introduced the 800 Series Hybrid, a new version of its 800 series of multi-layered extrusion tooling. The 800 Series Hybrid, according to Guill, retains the benefits of the overall 800 series: compact design, low residence time and a common deflector bore that eliminates tolerance stack up. But company officials say the 800 Series Hybrid also boasts a hybrid design that incorporates the benefits of layer overlapping while reducing unnecessary complexity and making the technology more affordable for customers. The result is a less expensive, smaller extrusion tool for producing overlapping layers — a method used to reduce errors from gels breaking through a thin wall, weld lines, inconsistent wall thickness, plus material and process variations, according to Guill. –CN Guill West Warwick, R.I. www.guill.com 78

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Protolabs launches metal 3D printing production capabilities Digital manufacturing company Protolabs is taking its metal 3D printing service to another level. The company announced in June that it has launched metal 3D printing production capabilities. The new secondary processes are meant to improve the strength, dimensional accuracy and cosmetic appearance of metal parts so that they can be used beyond prototyping.

Enhanced inspection reporting is also available.

Protolabs officials are touting the new capabilities as ideal for complex surgical instruments, surgical guides, patient-matched orthopedics and assistant devices. –CN Protolabs Maple Plain, Minn. www.protolabs.com

Qosina medtech components product catalog turns 40 Qosina in June announced the release of the 40th-anniversary edition of its product catalog, featuring more than 5,000 stock components available to medical device and pharmaceutical companies. Qosina added nearly 400 new components to its latest print catalog. The catalog also includes: • Material and measurement details on each product.

• More detailed and descriptive product features.

• A dedicated ISO 80369 chapter, as well as ISO 80369 callouts on applicable products.

• A list of recommended sterilization methods.

• Conversion charts that assist with calculation of metric, weight and length measurements.

Visit Qosina’s website at www.qosina.com/requests/catalog to request a complimentary copy of the 2020 Qosina product catalog. Founded in 1980, Qosina supplies thousands of OEM single-use components to the medical and pharmaceutical industries. –CN Qosina Ronkonkoma, N.Y. www.qosina.com

www.medicaldesignandoutsourcing.com

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